12916 Federal Register / Vol. 76, No. 46 / Wednesday, March 9, 2011 / Proposed Rules 

Instructions: 

* * * * * 

6. * * * 

(i) One or more tables, charts, or 

graphs depicting the portfolio holdings 

of the Registrant by reasonably 

identifiable categories (e.g., type of 

security, industry sector, geographic 

region, credit quality, or maturity) 

showing the percentage of net asset 

value or total investments attributable to 

each. If the Registrant has sub-accounts, 

provide the information separately for 

each sub-account. The categories and 

the basis of presentation (e.g., net asset 

value or total investments) should be 

selected, and the presentation should be 

formatted, in a manner reasonably 

designed to depict clearly the types of 

investments made by the Registrant, 

given its investment objectives. If the 

Registrant uses the credit ratings, as 

defined in Section 3(a)(60) [15 U.S.C. 

78c(a)(60)] of the Exchange Act, 

assigned by a nationally recognized 

statistical rating organization 

(‘‘NRSRO’’), as defined in Section 

3(a)(62) of the Exchange Act [15 U.S.C. 

78c(a)(62)], to categorize the credit 

quality of portfolio holdings, it should 

use the credit ratings of only one 

NRSRO except in the case of portfolio 

holdings that are not rated by that 

NRSRO. If credit ratings of that NRSRO 

are not available for certain holdings, 

the Registrant must briefly discuss the 

methodology for determining credit 

quality for such holdings, including, if 

applicable, the use of credit ratings 

assigned by another NRSRO. 

* * * * * 

PART 274—FORMS PRESCRIBED 

UNDER THE INVESTMENT COMPANY 

ACT OF 1940 

10. Form N–MFP (referenced in 

§ 274.201) is amended by: 

a. Revising Item 33; 

b. Removing Item 34; 

c. Revising Item 37.b; 

d. Removing Item 37.c; 

e. Removing Items 38.b and 38.c; 

f. Removing Items 39.c and 39.d; 

g. Redesignating Items 35 through 46 

as Items 34 through 45; and 

h. In redesignated Item 38, replacing 

‘‘Items 37 and 38’’ with ‘‘Items 36 and 

37’’. 

The revisions read as follows: 

Note: The text of Form N–MFP does not, 

and this amendment will not, appear in the 

Code of Federal Regulations. 

Form N–MFP 

* * * * * 

Item 33 

Indicate whether the security is a First 

Tier Security, a Second Tier Security or 

no longer an Eligible Security. 

* * * * * 

Item 37 

* * * * * 

b. The period remaining until the 

principal amount of the security may be 

recovered through the Demand Feature. 

Dated: March 3, 2011. 

By the Commission. 

Elizabeth M. Murphy, 

Secretary. 

[FR Doc. 2011–5184 Filed 3–8–11; 8:45 am] 

BILLING CODE 8011–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 310 

[Docket No. FDA–1981–N–0012] (Formerly 

Docket No. 1981N–0022) 

RIN 0910–AF45 

Benzocaine; Weight Control Drug 

Products for Over-the-Counter Human 

Use 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing a 

proposed rule to reclassify benzocaine 

from its previously proposed 

monograph status (category I) for overthe-counter (OTC) weight control use to 

nonmonograph status. Although, in the 

Federal Register of February 26, 1982, 

an advanced notice of proposed 

rulemaking (ANPR) included the 

recommendation of an Advisory Panel, 

consisting of health care providers from 

outside FDA, recommended that 

benzocaine should be generally 

recognized as safe and effective 

(GRASE) for weight control, this 

document includes our first evaluation 

of benzocaine for this use. Based on our 

evaluation of the available data and 

information, we have tentatively 

concluded that the data are not 

sufficient to support the safety and 

effectiveness of benzocaine for this use. 

This proposed rule, if finalized, would 

require an approved new drug 

application (NDA) or abbreviated new 

drug application (ANDA) for the 

marketing of OTC weight control 

products containing benzocaine. 

DATES: Submit written or electronic 

comments on the proposed rule by June 

7, 2011. See section IX of this document 

for information on the proposed 

effective date of this proposed rule. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–1981–N– 

0012 (formerly Docket No. 1981N–0022 

and RIN No. 0910–AF45 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. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. FDA–1981–N–0012 

(formerly Docket No. 1981N–0022) and 

RIN No. 0910–AF45 for this rulemaking. 

All comments received may be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Michelle M. Jackson, Center for Drug 

Evaluation and Research (HFD–560), 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 22, MS 

5411, Silver Spring, MD 20993–0002, 

301–796–2090. 

SUPPLEMENTARY INFORMATION: 

I. Purpose of This Document 

In the Federal Register of February 

26, 1982, we (FDA) published an ANPR 

to establish a monograph for OTC 

weight control drug products. The 

ANPR included the recommendations of 

an Advisory Review Panel on the OTC 

Miscellaneous Internal Drug Products 

(the Panel) that evaluated all OTC 

weight control drug products on the 

market at the time the OTC drug review 

began in 1972. The Panel consisted of 


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1Consistent with the principles explained 

previously, the OTC drug review regulations in 21 

CFR 330.10 specify the considerations and evidence 

required to establish both safety and effectiveness. 

scientists and health care providers 

from outside FDA. The Panel concluded 

that ‘‘benzocaine is safe for oral use as 

an OTC anorectic in a dose of 3 to 15 

milligrams (mg) in gum, lozenges, or 

candy’’ and that ‘‘benzocaine in the form 

of gum, lozenges, or candy is an 

effective OTC drug product for weight 

control’’ (47 FR 8466 at 8474). The Panel 

believed that benzocaine numbed the 

oral cavity (including the taste buds), 

thereby discouraging food consumption 

and decreasing caloric intake. 

We reviewed the information and data 

available to the Panel as well as 

information and data that has been 

developed since the Panel met to help 

us determine whether benzocaine is 

GRASE when used in OTC weight 

control drug products. Under the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act), all ‘‘new drugs’’ are 

required to obtain approval under 

section 505 of the FD&C Act (21 U.S.C. 

355) prior to marketing. Most drugs are 

‘‘new drugs’’ under the FD&C Act; 

however, a drug is excluded from being 

a ‘‘new drug’’ (and therefore is not 

required to obtain approval under 

section 505) if it is ‘‘generally 

recognized, among experts qualified by 

scientific training and experience to 

evaluate the safety and effectiveness of 

drugs, as safe and effective for use under 

the conditions prescribed, 

recommended, or suggested in the 

labeling thereof.’’ (21 U.S.C. 321(p)(1)).1

As explained in this document, we 

tentatively conclude that the existing 

evidence is inadequate to establish that 

OTC weight control drug products 

containing benzocaine are GRASE. 

Accordingly, we are proposing to 

classify benzocaine as nonmonograph 

(i.e., not GRASE) for use in OTC weight 

control drug products. If this proposed 

rule becomes a final rule, OTC weight 

control drug products containing 

benzocaine will require an approved 

NDA or ANDA. Studies that may help 

demonstrate the safety and effectiveness 

of weight loss drug products are 

described in an FDA guidance entitled 

‘‘Developing Products for Weight 

Management’’ (Ref. 1). 

II. Rulemakings and Petitions for OTC 

Weight Control Drug Products 

The Panel responsible for evaluating 

OTC weight control drug products 

recommended that benzocainecontaining drug products be deemed 

GRASE for use in OTC weight control 

drug products. The Panel’s 

recommendations were published in the 

Federal Register as an ANPR for OTC 

weight control products in 1982 (47 FR 

8466). 

Following publication of the 1982 

ANPR, Thompson Medical Co., a 

manufacturer of OTC weight control 

drug products, submitted two citizen 

petitions, one in 1990 and another in 

1992, to support the effectiveness of 

benzocaine for use as an appetite 

suppressant (Refs. 2 and 3). The 1990 

petition (Ref. 2) included a clinical 

study by Collipp (Refs. 4 and 5) and a 

summary of a clinical study by Piscano 

and Lichter (Ref. 6) as data supporting 

the effectiveness of benzocaine as an 

appetite suppressant. We responded to 

the manufacturer’s 1990 petition (Ref. 7) 

reviewing the data submitted in the 

petition and explaining our finding that 

the data did not provide substantial 

evidence from adequate and wellcontrolled studies to support the 

effectiveness of benzocaine for weight 

control use. 

The 1992 petition (Ref. 3) was 

submitted in response to our 1991 letter. 

The petition provided two unpublished 

statistical reevaluations of the Collipp 

study, arguing that this data supported 

finding benzocaine GRASE for use in 

OTC weight control drug products. We 

responded to the petition in 1993 (Ref. 

8), stating that the reevaluations of the 

Collipp study did not substantiate the 

claim of effectiveness of benzocaine for 

use in weight control. The two 

reanalyses of the Collipp data include: 

(1) An analysis of covariance excluding 

subjects that failed to meet either the 

age or the degree of overweight 

inclusion criteria, and (2) a hierarchical 

regression model to determine the effect 

of benzocaine after attempting to control 

for any familial effects. Neither of these 

analyses adequately addressed the three 

main problems that were listed in the 

1991 response: (1) Possible breaking of 

the blind; (2) imbalance in the sample 

for important variables (age by family 

status); and (3) lack of randomization 

within families, affecting the 

independence of observations. These 

problems potentially biased the data 

affecting the interpretability of the study 

results. 

Subsequent to our letter, we received 

draft protocols for effectiveness studies 

(Ref. 9) from the same manufacturer, 

which were intended to generate 

support for a GRASE finding. We sent 

recommendations on the draft protocols 

in 1992 (Ref. 10), but have not yet 

received any study results. 

III. Efficacy Evaluation 

We are proposing that benzocaine be 

classified as nonmonograph at any 

concentration for use in OTC weight 

control drug products. This conclusion 

is based in part on our review of the 

effectiveness data that was submitted to 

the Panel (Refs. 11 through 17) and 

additional data submitted to us after 

publication of the 1982 ANPR, 

including the two petitions and draft 

protocols described previously (Refs. 2, 

3, and 9). In our responses to the 

petitions, we explained in detail why 

we did not find the available data 

adequate to support a determination 

that benzocaine is generally recognized 

as effective (GRAE) for this use (Refs. 7, 

8, and 10). In this document, we 

summarize the available data and 

limitations that prevent us from finding 

benzocaine GRAE for use in OTC weight 

control drug products. We have not 

received any additional data from any 

company or citizen since our 1992 

response letter (Ref. 10) discussed 

previously; and we are not aware of any 

safety or effectiveness studies for 

benzocaine in OTC weight control drug 

products conducted since 1992. 

In the following sections, we will first 

describe the studies reviewed by the 

Panel. After reviewing the data and 

findings from these studies, we will 

explain why the Agency has concluded 

that these studies do not support a 

finding that benzocaine is GRAE for use 

in OTC weight control drug products. 

A. Non-Clinical Studies 

1. Review of Studies 

In the ANPR, we reported that the 

Panel considered a few nonclinical 

studies (Refs. 11, 12, and 13) on 

benzocaine for weight control. One of 

the factors involved in overeating and 

resulting obesity is the need to satisfy 

the sense of taste. Horowitze (Ref. 11) 

and Rosner (Ref. 12) showed that there 

appears to be a decreased ability to 

detect degrees of sweetness by taste 

perception after chewing gum 

containing benzocaine. Coons (Ref. 13) 

demonstrated the effects of a local 

anesthetic on hunger reduction in rats. 

The Panel considered this study to be an 

objective demonstration of the 

effectiveness of a local anesthetic on 

hunger reduction. 

2. Analysis of Studies 

We do not believe these studies 

support a GRAE determination because 

they do not demonstrate that decreased 

taste perception or decreased hunger 

results in weight loss. To find 

benzocaine GRAE based in part on these 

types of studies, we would also need 

data demonstrating what level of 

decrease in taste perception or hunger 

actually resulted in a ‘‘clinically 


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significant benefit of the type claimed’’ 

(i.e., weight loss) as required under 

§ 330.10(a)(4)(ii) (21 CFR 

330.10(a)(4)(ii)). 

B. Clinical Studies 

1. Review of Studies 

The Panel also considered clinical 

studies that included weight loss as an 

endpoint. Gould (Refs. 14 and 15) 

assessed various case reports citing 1.5 

to 2.0 pounds (lbs) per week weight loss 

using lozenges containing benzocaine 

and essential oils in conjunction with 

dietary restrictions. Plotz (Ref. 16) 

conducted an uncontrolled, nonrandomized 10-week study of 50 

overweight adults (12 to 102 lbs 

overweight). The subjects were 

instructed to chew one or two pieces of 

gum for 5 or 10 minutes followed by a 

glass of water, just before meals. If 

subjects became hungry between meals, 

they could chew gum every few hours. 

The study results showed weight loss 

(2 pounds per week) in 45 of 50 patients 

using the benzocaine gum in 

conjunction with dietary restrictions. 

McClure and Brush (Ref. 17) 

conducted a placebo-controlled, 

randomized, double-blinded 21-week 

study of 308 overweight adults (255 

females and 53 males). The subjects 

were divided into five paired treatment 

groups: 

• Group 1: Dextroamphetamine 

sulfate (10 mg, daily) 

• Group 2: OTC proprietary appetite 

suppressant (AYDS) 

• Group 3: Dietary restriction (800 to 

1,200 calories daily) 

• Group 4: Glucose hard candy 

containing benzocaine, caffeine, and 

vitamins (benzocaine group) 

• Group 5: Glucose candy only 

(control group) 

Over the course of 4 weeks, 170 

participants dropped out of the study 

(37 participants from the 

dextroamphetamine group, 43 

participants from the AYDS group, 51 

participants from the dietary restriction 

group, 9 participants from the 

benzocaine group, and 30 participants 

from the control group). The 

investigators reported an average weight 

loss during the first 4 weeks of 4.6 lbs 

for the glucose (control) group and 12.1 

lbs for the benzocaine group. After 21 

weeks, the control group lost a weekly 

average of 0.60 lbs as compared to 2.20 

lbs for the benzocaine group. 

In addition to these studies reviewed 

by the Panel, as described previously, 

we also reviewed clinical studies 

submitted by a manufacturer of OTC 

weight control drug products in two 

petitions. The studies provided in the 

petitions included weight loss as an 

endpoint. Reports purporting to be two 

studies by Collipp (one published and 

one unpublished) were submitted. 

These reports appear to be the same 

study (Refs. 4 and 5). The Collipp study 

was designed to be a 6-week, doubleblind, placebo-controlled, randomized 

trial comparing benzocaine (5 mg) 

lozenges with placebo lozenges that 

were identical in appearance (Ref. 4). 

Male or female subjects who weighed 15 

to 30 percent more than the ideal weight 

for their body frame as determined from 

Metropolitan Life Insurance Co. weight 

tables and were between 14 and 55 

years of age were eligible for enrollment. 

Subjects were recruited from the same 

families. Subjects were instructed to 

follow a 1,250 calorie diet and to take 

1 to 2 lozenges 10 minutes before meals, 

1 lozenge instead of dessert, and 1 or 2 

lozenges between meals. Subjects were 

also instructed to drink a glass of water, 

tea, coffee, or other non-caloric beverage 

with each lozenge ingestion. Body 

weight was measured at week 0 and 

biweekly for the next 6 weeks. Subjects 

were also asked to rate the average 

quality of between-meal appetite 

suppression as mild, moderate, or 

complete. 

The study results showed that the 

mean body weight decreased from week 

0 in both the active treatment and 

placebo groups. Subjects treated with 

benzocaine had a mean weight loss that 

was statistically significant (p ≤: 0.001) 

at all time points. The mean weight loss 

during the study was approximately 

twice as great for subjects treated with 

benzocaine (¥3.5, ¥4.9, and ¥6.0 at 2, 

4, and 6 weeks, respectively) compared 

to placebo (¥2.1, ¥2.9, and ¥2.7 at 2, 

4, and 6 weeks, respectively). The 

manufacturer also submitted a study by 

Piscano and Lichter (Ref. 6) which 

consisted of a 1-page summary 

describing an 8-week uncontrolled trial 

involving 26 children. The summary 

listed the baseline weight, final weight, 

and weight loss of each subject. The 

summary results showed that the 

subjects lost approximately 0.5 lbs/ 

week. There was no protocol 

description and no statistical analysis. 

2. Analysis of Studies 

We found a lack of substantial 

evidence consisting of adequate and 

well-controlled studies, as required in 

§ 330.10(a)(4)(ii), on which to base a 

determination of the effectiveness of 

benzocaine in OTC weight control drug 

products. In general, the clinical studies 

reviewed by the Panel (Refs. 14 through 

17) are inadequately controlled, and 

study results were not clinically and 

statistically significant. For example, 

among other limitations, the Gould 

studies (Refs. 14 and 15) were not wellcontrolled, as these studies consisted of 

case reports. Similarly, the Plotz study 

(Ref. 16) was not well controlled, being 

both uncontrolled and non-randomized. 

Finally, as detailed in our 1993 response 

(Ref. 8), the McClure and Brusch study 

(Ref. 17) had significant methodological 

flaws including potential issues with 

subject recruitment, inconsistent follow 

up of subjects and inadequate 

assessment of baseline characteristics. 

The materials submitted in the 

petition were also insufficient to 

establish the effectiveness of benzocaine 

in OTC weight control products. For 

example, the Pisano and Lichter (Ref. 6) 

study was not adequate and wellcontrolled as it consisted of case reports, 

did not include a protocol description 

and did not provide a statistical 

analysis. Similarly, the Collipp study 

and the reevaluations of the study 

submitted in the petitions do not 

provide detail regarding study design 

and outcomes sufficient to show 

benzocaine is GRASE for use in weight 

control. Specifically, the Collipp study 

had a significant number of limitations 

that prevent us from concluding that 

benzocaine is GRAE for weight control: 

• Non-random selection of subjects 

• Possible breaking of blinding 

• Analysis did not account for a lack 

of independence among subjects within 

the same family, potentially affecting 

the study’s findings 

It is important to note that after 

providing the petitioning manufacturer 

with a response describing these 

limitations, we received a protocol for a 

further study from the manufacturer 

(Ref. 9). We provided feedback on the 

protocol in 1992 (Ref. 10), but we have 

not yet received the study results from 

the manufacturer. In order to establish 

effectiveness, additional data are still 

needed to show that benzocaine causes 

a clinically and statistically significant 

weight loss when compared with 

placebo. The industry is advised to 

consult a recently published FDA 

guidance on the development of 

products for weight management about 

the requirement of clinical data (Ref. 1). 

IV. Safety Evaluation 

We are not aware of adequate data to 

demonstrate that OTC weight control 

drug products containing benzocaine 

are generally recognized as safe (GRAS) 

as defined under § 330.10(a)(4)(ii). 

Under this regulatory provision, support 

for a GRAS showing ‘‘shall consist of 

adequate tests by methods reasonably 

applicable to show the drug is safe 

under the prescribed, recommended, or 

suggested conditions of use.’’ We believe 


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2See 5 U.S.C. 553(d). 

that the safety of the Panel’s proposed 

benzocaine dosing for OTC weight 

control use (multiple 3 to 15 mg doses 

for up to 3 months) has not been 

adequately established. Additional 

safety data is needed to establish dosage 

limitations or other aspects of the 

labeling. Our current recommendation 

as to what would constitute adequate 

testing for a weight control drug product 

is described in our guidance on weight 

control drug products (Ref. 1). 

V. Analysis of Impacts 

We have examined the impacts of this 

proposed rule under Executive Order 

12866 and the Regulatory Flexibility Act 

(5 U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (Public 

Law 104–4). Executive Order 12866 

directs agencies to assess all costs and 

benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity). We believe that 

this proposed rule is not a significant 

regulatory action as defined by the 

Executive order. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because few products will 

likely be affected and those effects 

would probably be small, we do not 

believe that this proposed rule would 

have a significant economic impact on 

a substantial number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $135 

million, using the most current (2009) 

Implicit Price Deflator for the Gross 

Domestic Product. We do not expect 

this proposed rule to result in any 

1-year expenditure that would meet or 

exceed this amount. 

If this proposed rule is finalized, OTC 

marketing of weight control drug 

products containing benzocaine for this 

use will cease, unless a product is 

approved under an NDA or ANDA. In 

this proposed rule, we tentatively 

conclude that OTC weight control drug 

products containing benzocaine lack 

sufficient evidence to support a finding 

that such products are GRASE, and that 

finalization of the regulatory status of 

this ingredient will benefit consumers 

by removing from the marketplace 

products that have not been shown to be 

safe and effective. We do not expect this 

rule to have a significant effect on 

industry as a whole, as we have only 

been able to identify one company that 

manufactures a benzocaine-containing 

OTC weight control drug product. 

We have few alternatives available to 

us when we determine there are no data 

available to demonstrate that an active 

ingredient is GRASE. Even without 

evidence of harm caused by the use of 

these products, they cannot remain on 

the market because there is no evidence 

that they are safe and effective. 

Accordingly, we have proposed a 

30-day period within which companies 

may remove benzocaine-containing 

weight control drug products from the 

market. We believe the only alternative 

to this approach is a longer 

implementation period.2 We could 

allow a longer implementation period so 

manufacturers would have time to 

submit additional effectiveness and 

safety data, but if we took this approach, 

consumers would be unnecessarily 

exposed to products that have not been 

shown to be effective or safe. 

VI. Paperwork Reduction Act of 1995 

This proposed rule contains no 

collections of information. Therefore, 

clearance by the Office of Management 

and Budget under the Paperwork 

Reduction Act of 1995 is not required. 

VII. Environmental Impact 

We have determined under 21 CFR 

25.31(a) that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

VIII. Federalism 

We have analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. Section 

4(a) of the Executive order requires 

agencies to ‘‘construe * * * a Federal 

statute to preempt State law only where 

the statute contains an express 

preemption provision or there is some 

other clear evidence that the Congress 

intended preemption of State law, or 

where the exercise of State authority 

conflicts with the exercise of Federal 

authority under the Federal statute.’’ 

The sole statutory provision giving 

preemptive effect to the proposed rule is 

section 751 of the act (21 U.S.C. 379r). 

We believe that the preemptive effect 

of this proposed rule, if finalized, would 

be consistent with Executive Order 

13132. Through the publication of this 

proposed rule, we are providing notice 

and an opportunity for State and local 

officials to comment on this rulemaking. 

IX. Proposed Effective Date 

Due to effectiveness concerns 

discussed in this document, any final 

rule based on this proposal would 

become effective 30 days after the date 

of its publication. Manufacturers are 

urged to comply voluntarily with this 

proposed rule and to cease OTC 

marketing at the earliest possible date. 

X. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

under Docket No. FDA–1981–N–0012 

(formerly 1981N–0022) and may be seen 

by interested persons between 9 a.m. 

and 4 p.m., Monday through Friday. 

(FDA has verified the Web site address, 

but we are not responsible for any 

subsequent changes to the Web site after 

this document publishes in the Federal 

Register.) 

1. FDA, ‘‘Draft Guidance for Industry— 

Developing Products for Weight 

Management,’’ February 2007, http:// 

www.fda.gov/downloads/Drugs/

GuidanceComplianceRegulatory

Information/Guidances/ucm071612.pdf, 

accessed on August 27, 2010. 

2. Comment No. CP12, Docket No. FDA– 

1981–N–0012 (formerly 1981N–0022), 

Division of Dockets Management System. 

3. Comment No. CP15, Docket No. FDA– 

1981–N–0012 (formerly 1981N–0022), 

Division of Dockets Management System. 

4. Collipp, P. J., ‘‘The Treatment of Exogenous 

Obesity by Medicated Benzocaine 

Candy: A Double-Blind PlaceboControlled Study,’’ in OTC Vol. 170010, 

Docket No. FDA–1981–N–0012 (formerly 

1981N–0022), Division of Dockets 

Management. 

5. Collipp, P. J., ‘‘The Treatment of Exogenous 

Obesity by Medicated Benzocaine 

Candy: A Double Blind Placebo Study,’’ 

Obesity/Bariatric Medicine, 10:123–125, 

1981. 

6. Piscano, J. and H. Lichter, ‘‘A Matter of 

Taste,’’ Fredrick Fell Publishers, Inc., 

New York, New York, pp. 42–64, 1979. 

7. Comment No. LET82, Docket No. FDA– 

1981–N–0012 (formerly 1981N–0022), 

Division of Dockets Management System. 

8. Comment No. LET87, Docket No. FDA– 

1981–N–0012 (formerly 1981N–0022), 

Division of Dockets Management System. 

9. Comment No. PR9, Docket No. FDA–1981– 

N–0012 (formerly 1981N–0022), Division 

of Dockets Management System. 

10. Comment No. LET84, Docket No. FDA– 

1981–N–0012 (formerly 1981N–0022), 

Division of Dockets Management System. 


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11. Horowitz, S. and R. P. Scalici, ‘‘Results of 

Sensory Panel Tests on Slim-Mint 

Chewing Gum,’’ in OTC Vol. 170010, 

Docket No. FDA–1981–N–0012 (formerly 

1981N–0022), Division of Dockets 

Management. 

12. Rosner, L., ‘‘To Determine the Effect of 

Chewing Slim-Mint Gum Upon Taste 

Perception, Particularly Toward 

Sweetness,’’ in OTC Vol. 170010, Docket 

No. FDA–1981–N–0012 (formerly 

1981N–0022), Division of Dockets 

Management. 

13. Summary Minutes of the 11th meeting of 

the Advisory Review Panel on OTC 

Miscellaneous Internal Drug Products 

held on May 9–10, 1976 in OTC Vol. 

170010, Docket No. FDA–1981–N–0012 

(formerly 1981N–0022), Division of 

Dockets Management. 

14. Gould, W. L., ‘‘On the Use of a 

Medicament to Reduce the Appetite in 

the Treatment of Obesity and Other 

Conditions,’’ New York State Journal of 

Medicine, 47:981–983, 1947. 

15. Gould, W. L., ‘‘Obesity and Hypertension: 

The Importance of a Safe Compound to 

Control Appetite,’’ North Carolina 

Medical Journal, 11:327–334, 1950. 

16. Plotz, M., ‘‘Obesity,’’ Medical Times, 

86:860–863, 1958. 

17. McClure, C. W. and C. A. Brusch, 

‘‘Treatment of Oral Syndrome Obesity 

with Non traditional Appetite Control 

Plan,’’ Journal of the American Women’s 

Medical Association, 28:239–248, 1973. 

List of Subjects in 21 CFR Part 310 

Administrative practice and 

procedure, Drugs, Labeling, Medical 

devices, Reporting and recordkeeping 

requirements. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, it is proposed that 

21 CFR part 310 be amended as follows: 

PART 310—NEW DRUGS 

1. The authority citation for 21 CFR 

part 310 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 355, 360b–360f, 360j, 361(a), 371, 374, 

375, 379e; 42 U.S.C. 216, 241, 242(a), 262, 

263b–263n. 

2. Section 310.545 is amended by 

adding paragraphs (a)(20)(i), (a)(20)(ii), 

and (a)(20)(iii); by revising paragraph (d) 

introductory text; and by adding 

paragraph (d)(40) to read as follows: 

§ 310.545 Drug products containing 

certain active ingredients offered over-thecounter (OTC) for certain uses. 

(a) * * * 

(20) * * * 

(i) [Reserved] 

(ii) [Reserved] 

(iii) Approved as of [DATE 30 DAYS 

AFTER DATE OF PUBLICATION OF 

THE FINAL RULE IN THE FEDERAL 

REGISTER]. 

Benzocaine 

* * * * * 

(d) Any OTC drug product that is not 

in compliance with this section is 

subject to regulatory action if initially 

introduced or initially delivered for 

introduction into interstate commerce 

after the dates specified in paragraphs 

(d)(1) through (d)(40) of this section. 

* * * * * 

(40) [DATE 30 DAYS AFTER DATE 

OF PUBLICATION OF THE FINAL 

RULE IN THE FEDERAL REGISTER], 

for products subject to paragraph 

(a)(20)(iii) of this section. 

Dated: March 2, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5145 Filed 3–8–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF THE INTERIOR 

Office of Surface Mining Reclamation 

and Enforcement 

30 CFR Part 938 

[PA–157–FOR; OSM 2010–0011] 

Pennsylvania Regulatory Program 

AGENCY: Office of Surface Mining 

Reclamation and Enforcement (OSM), 

Interior. 

ACTION: Proposed rule; public comment 

period and opportunity for public 

hearing on removal of required 

amendment. 

SUMMARY: We are announcing receipt of 

a request to remove a required 

amendment to the Pennsylvania 

regulatory program (the ‘‘Pennsylvania 

program’’) under the Surface Mining 

Control and Reclamation Act of 1977 

(SMCRA or the Act). In response to a 

required program amendment codified 

in the Federal regulations, Pennsylvania 

has submitted rationale that it believes 

supports its position that current 

program provisions are sufficient to 

render its program no less effective than 

the Federal requirements and, therefore, 

no amendment is necessary. The 

required amendment pertains to 

regulatory exemptions for coal 

extraction incidental to the extraction of 

other minerals. 

This document gives the times and 

locations that the Pennsylvania program 

and this submittal are available for your 

inspection, the comment period during 

which you may submit written 

comments, and the procedures that we 

will follow for the public hearing, if one 

is requested. 

DATES: We will accept written 

comments until 4 p.m., local time April 

8, 2011. If requested, we will hold a 

public hearing on April 4, 2011. We will 

accept requests to speak until 4 p.m., 

local time on March 24, 2011. 

ADDRESSES: You may submit comments, 

identified by ‘‘PA–157–FOR; Docket ID: 

OSM–2010–0011’’ by either of the 

following two methods: 

Federal eRulemaking Portal: http:// 

www.regulations.gov. The proposed rule 

has been assigned Docket ID: OSM– 

2010–0011. If you would like to submit 

comments through the Federal 

eRulemaking Portal, go to http:// 

www.regulations.gov and follow the 

instructions. 

Mail/Hand Delivery/Courier: Mr. 

George Rieger, Chief, Pittsburgh Field 

Division, Office of Surface Mining 

Reclamation and Enforcement, 

Harrisburg Transportation Center, 415 

Market St., Suite 304, Harrisburg, PA 

17101. 

Instructions: For detailed instructions 

on submitting comments and additional 

information on the rulemaking process, 

see the ‘‘Public Comment Procedures’’ 

heading of the SUPPLEMENTARY

INFORMATION section of this document. 

Docket: In addition to obtaining 

copies of documents at http:// 

www.regulations.gov, information may 

also be obtained at the addresses listed 

below during normal business hours, 

Monday through Friday, excluding 

holidays. You may receive one free copy 

of the amendment by contacting OSM’s 

Pittsburgh Field Division Office. 

George Rieger, Chief, Pittsburgh Field 

Division, Office of Surface Mining 

Reclamation and Enforcement, 

Harrisburg Transportation Center, 415 

Market St., Suite 304, Harrisburg, 

Pennsylvania 17101, Telephone: (717) 

782–4036, E-mail: grieger@osmre.gov. 

Thomas Callaghan, P.G., Director, 

Bureau of Mining and Reclamation, 

Pennsylvania Department of 

Environmental Protection, Rachel 

Carson State Office Building, P.O. Box 

8461, Harrisburg, Pennsylvania 

17105–8461, Telephone: (717) 787– 

5103, E-mail: tcallaghan@state.pa.us. 

FOR FURTHER INFORMATION CONTACT: 

George Rieger, Telephone: (717) 782– 

4036. E-mail: grieger@osmre.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background on the Pennsylvania Program 

II. Description of the Request 

III. Public Comment Procedures 

IV. Procedural Determinations 

I. Background on the Pennsylvania 

Program 

Section 503(a) of the Act permits a 

State to assume primacy for the 


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