61148 Federal Register / Vol. 69, No. 199 / Friday, October 15, 2004 / Rules and Regulations 

College Station, TX, Easterwood Field, GPS 

RWY 10, Orig-A, CANCELLED 

College Station, TX, Easterwood Field, GPS 

RWY 16, Orig, CANCELLED 

College Station, TX, Easterwood Field, GPS 

RWY 28, Orig, CANCELLED 

College Station, TX, Easterwood Field, GPS 

RWY 34, Orig-A, CANCELLED 

Eagle Lake, TX, Eagle Lake, RNAV (GPS) 

RWY 17, Orig 

Eagle Lake, TX, Eagle Lake, RNAV (GPS) 

RWY 35, Orig 

Eagle Lake, TX, Eagle Lake, VOR RWY 17, 

Amdt 5 

El Paso, TX, El Paso Intl, VOR RWY 26L, 

Amdt 30 

Houston, TX, William P. Hobby, NDB RWY 

4, Amdt 33, CANCELLED 

Lawrenceville, VA, Lawrenceville/Brunswick 

Muni, RNAV (GPS) RWY 18, Orig 

Lawrenceville, VA, Lawrenceville/Brunswick 

Muni, RNAV (GPS) RWY 36, Orig 

Sheboygan, WI, Sheboygan County 

Memorial, RNAV (GPS) RWY 3, Orig 

Sheboygan, WI, Sheboygan County 

Memorial, RNAV (GPS) RWY 13, Orig 

Sheboygan, WI, Sheboygan County 

Memorial, RNAV (GPS) RWY 31, Orig 

Sturgeon Bay, WI, Door County Cherryland, 

NDB RWY 2, Amdt 11 

Sturgeon Bay, WI, Door County Cherryland, 

SDF RWY 2, Amdt 7 

Sturgeon Bay, WI, Door County Cherryland, 

RNAV (GPS) RWY 2, Orig 

Sturgeon Bay, WI, Door County Cherryland, 

RNAV (GPS) RWY 10, Orig 

Sturgeon Bay, WI, Door County Cherryland, 

RNAV (GPS) RWY 20, Orig 

Sturgeon Bay, WI, Door County Cherryland, 

RNAV (GPS) RWY 28, Orig 

Afton, WY, Afton Muni, RNAV (GPS) RWY 

16, Amdt 1 

Afton, WY, Afton Muni, RNAV (GPS) RWY 

34, Amdt 1

The FAA published several Amendments 

in Docket No. 30424, Amdt No. 3105 to Part 

97 of the Federal Aviation Regulations (Vol 

69, FR No. 181, Pages 56161–56163; dated 

Monday, September 20, 2004) under Section 

97.33 effective November 25, 2004 which are 

hereby rescinded in their entirety:

Payson, AZ, Payson, RNAV (GPS)–A, Amdt 

1A 

Inyokern, CA, Inyokern, RNAV (GPS) Y RWY 

2, Orig-A 

Battle Mountain, NV, Battle Mountain, RNAV 

(GPS) RWY 3, Orig-A

[FR Doc. 04–22945 Filed 10–14–04; 8:45 am] 

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 350

[Docket No. 1978N–0064]

RIN 0910–AC89

Antiperspirant Drug Products for Overthe-Counter Human Use; Final 

Monograph; Partial Stay; Reopening of 

the Administrative Record

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Final rule; partial stay; 

reopening of the administrative record.

SUMMARY: The Food and Drug 

Administration (FDA) is staying part of 

the final monograph (FM) for over-thecounter (OTC) antiperspirant drug 

products that published in the Federal 

Register on June 9, 2003 (68 FR 34273). 

The FM established conditions under 

which OTC antiperspirant drug 

products are generally recognized as 

safe and effective (GRASE) and not 

misbranded. This partial stay applies 

only to the labeling claims for enhanced 

duration in § 350.50(b)(3) and (b)(5) (21 

CFR 350.50(b)(3) and (b)(5)). In 

addition, FDA is reopening the 

administrative record for the rulemaking 

on OTC antiperspirant drug products to 

allow for comment and data specifically 

on the information requested in this 

document. FDA is taking this action in 

response to a citizen petition containing 

data demonstrating that FDA’s 

effectiveness testing guidelines for OTC 

antiperspirant drug products may 

support an enhanced duration claim 

greater than 24 hours. This action is part 

of FDA’s ongoing review of OTC drug 

products.

DATES: This rule is effective December 9, 

2004. The limitation of the enhanced 

duration claim to 24 hours (21 CFR 

350.50(b)(3) and (b)(5)) is stayed until 

further notice.

Submit written or electronic 

comments and data by April 13, 2005. 

The administrative record will remain 

open until April 13, 2005.

ADDRESSES: You may submit comments, 

identified by Docket No. 1978N–0064 by 

any of the following methods:

• Federal eRulemaking Portal: http://

www.regulations.gov. Follow the 

instructions for submitting comments.

• Agency Web site: http://

www.fda.gov/dockets/ecomments. 

Follow instructions for submitting 

comments on the agency Web site.

• E-mail: fdadockets@oc.fda.gov. 

Include Docket No. 1978N–0064 in the 

subject line of your e-mail message.

• FAX: 301–827–6870.

• Mail/Hand delivery/Courier [For 

paper, disk, or CD-ROM submissions]: 

Division of Dockets Management, 5630 

Fishers Lane, rm. 1061, Rockville, MD 

20852.

Instructions: All submissions received 

must include the agency name and 

Docket No. 1978N–0064. All comments 

received will be posted without change 

to http://www.fda.gov/dockets/

ecomments, including any personal 

information provided. For detailed 

instructions on submitting comments 

and additional information on the 

rulemaking process, see the 

‘‘Comments’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document.

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.fda.gov/dockets/ecomments and/

or the Division of Dockets Management, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852.

FOR FURTHER INFORMATION CONTACT: Xin 

Zhou, Center for Drug Evaluation and 

Research (HFD–560), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–2222.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of October 10, 

1978 (43 FR 46694), FDA published an 

advance notice of proposed rulemaking 

(ANPRM) to establish a monograph for 

OTC antiperspirant drug products, 

together with the recommendations of 

the Advisory Review Panel on OTC 

Antiperspirant Drug Products (the 

Panel), which evaluated the data on 

these products. The Panel classified 

claims for enhanced duration of effect as 

Category III (more data needed) because 

the Panel did not receive any scientific 

data to support a claim of prolonged or 

enhanced duration of effect (43 FR 

46694 at 46728).

In the Federal Register of August 20, 

1982 (47 FR 36492), FDA issued a 

proposed rulemaking or tentative final 

monograph (TFM) for OTC 

antiperspirant drug products. To 

standardize the antiperspirant drug 

product effectiveness test, FDA also 

issued guidelines for effectiveness 

testing of antiperspirant drug products 

(47 FR 36492 at 36504). However, FDA 

did not include testing 

recommendations for an enhanced 

duration claim in these guidelines 

because the Panel had not 

recommended such guidelines and FDA 

Federal Register / Vol. 69, No. 199 / Friday, October 15, 2004 / Rules and Regulations 61149

received no comments on this subject in 

response to publication of the ANPRM.

In response to the TFM, FDA received 

data from 15 studies to support 

enhanced duration claims. FDA found 

the studies supportive of a 24-hour or 

all day protection claim and included 

such a claim in § 350.50(b)(3) and (b)(5) 

of the FM. However, FDA stated that 

claims of enhanced duration for more 

than 24 hours are nonmonograph 

because FDA had not received any data 

to demonstrate antiperspirant 

effectiveness for more than 24 hours 

according to the Panel’s criteria (68 FR 

34273 at 34278).

II. Partial Stay of Part 350

Following publication of the 

antiperspirant FM, a drug manufacturer 

and an association representing 

manufacturers submitted citizen 

petitions disagreeing with FDA’s 

decision to limit the enhanced duration 

claim to 24 hours (Refs. 1 and 2). 

Neither petition contained any 

effectiveness testing data to support 

enhanced duration claims beyond 24 

hours. However, the manufacturer 

subsequently submitted such data from 

two studies (Ref. 3).

FDA evaluated the data and the 

results demonstrate that a roll-on and a 

solid stick antiperspirant drug product 

are extra effective for 48 hours duration 

(i.e., sweat was reduced by at least 30 

percent in the majority of subjects up to 

48 hours after antiperspirant 

application). The protocol in the two 

studies followed FDA’s testing 

guidelines, with no significant 

deviations from those guidelines. The 

antiperspirant drug products used in the 

studies contained an active ingredient at 

a concentration allowed under the 

antiperspirant FM (§ 350.10 (21 CFR 

350.10)). Thus, FDA believes the study 

results suggest that FDA’s testing 

guidelines can be used to test enhanced 

duration claims of up to 48 hours. 

Accordingly, FDA is staying the 

enhanced duration claim limitation of 

24 hours (in § 350.50(b)(3) and (b)(5)) so 

that products labeled for enhanced 

duration claims greater than 24 hours 

and up to 48 hours can continue to be 

marketed while FDA reviews additional 

data on such claims. Manufacturers 

making such claims for their products 

should have supporting test data in their 

files. FDA will consider allowing 

enhanced duration claims of greater 

than 48 hours after it receives and 

evaluates data supporting such claims. 

This stay will remain in effect until 

further documentation is provided in a 

future issue of the Federal Register.

To the extent that 5 U.S.C. 553 applies 

to this action, it is exempt from notice 

and comment because it constitutes a 

rule of procedure under 5 U.S.C. 

553(b)(3)(A). Alternatively, FDAs 

implementation of this action without 

opportunity for public comment comes 

within the good cause exceptions in 5 

U.S.C. 553(b)(3)(B) and (d)(3) in that 

obtaining public comment is 

impracticable, unnecessary, and 

contrary to the public interest. FDA is 

staying the enhanced duration claim 

limitation of 24 hours in § 350.50(b)(3) 

and (b)(5) because FDA received and is 

reviewing data demonstrating an 

enhanced duration claim greater than 24 

hours. FDA is also reopening the 

administrative record and inviting the 

submission of additional comments and 

data related to the effectiveness of 

antiperspirant drug products for more 

than 24 hours. Following evaluation of 

submitted comments and data, FDA will 

propose amendments to § 350.50(b)(3) 

and (b)(5) and possibly other sections of 

part 350. Thus, there will be an 

opportunity for public comment on 

enhanced duration claims greater than 

24 hours within proposed amendments 

to part 350. In this final rule, FDA is 

providing an opportunity for comment 

on whether this partial stay should be 

modified or revoked.

III. Information Requested

In the antiperspirant FM, FDA stated 

that claims of enhanced duration for 

more than 24 hours are nonmonograph 

because FDA did not receive any data to 

demonstrate antiperspirant effectiveness 

for more than 24 hours (68 FR 34273 at 

34278). Because FDA has now received 

data demonstrating antiperspirant 

product effectiveness for 48 hours, FDA 

is reopening the administrative record 

to provide for additional submission of 

data and comments on enhanced 

duration effectiveness claims for 

antiperspirant drug products. FDA 

would like to evaluate additional data 

demonstrating antiperspirant 

effectiveness beyond 24 hours before 

including enhanced duration claims for 

longer time periods (e.g., 48 hours) in 

the FM. FDA will only include 

enhanced duration claims in the FM for 

time periods for which appropriate data 

have been submitted to demonstrate 

effectiveness.

A. Testing Conditions

To determine whether enhanced 

duration claims of effectiveness beyond 

24 hours are GRASE, FDA strongly 

encourages manufacturers to submit 

data that meet the following six 

conditions. First, studies should be 

conducted according to the testing 

guidelines referenced in 21 CFR 350.60, 

which are on file in the Division of 

Dockets Management (see ADDRESSES). 

These guidelines are available at http:/

/www.fda.gov/cder/otc/index.htm.

Second, studies should be conducted 

using antiperspirant drug products that 

contain active ingredients listed in 

§ 350.10. The test product ingredient 

and strength must be identified in the 

data submitted to FDA.

Third, FDA encourages interested 

parties to conduct enhanced duration 

effectiveness tests using different active 

ingredients and dosage forms. These 

data will demonstrate that enhanced 

duration claims determined by the 

testing guidelines are applicable to 

multiple active ingredient and dosage 

forms. Fourth, FDA would like data 

submitted from different testing 

laboratories. Ideally, the same 

antiperspirant drug product will be 

tested at multiple laboratories, to 

validate the reproducibility of the 

testing results.

Fifth, FDA believes that the test 

subject panel composition should reflect 

consumer demographics (Ref. 4) 

although the testing guidelines do not 

specify the panel composition. 

Although the testing guidelines do not 

specify the panel composition, FDA 

would like data from roughly equal 

numbers of men and women. It would 

also be informative if submitted studies 

also identified race or ethnicity of 

subjects. FDA would like to assure that 

the submitted study results demonstrate 

enhanced duration of effectiveness for 

the entire consumer population, not just 

a subset of the population.

Sixth, FDA is interested in reviewing 

data for antiperspirant drug products 

with standard effectiveness as well as 

products with extra effectiveness. FDA 

would like to determine whether 

enhanced duration claims are limited to 

extra effective antiperspirant drug 

products or whether enhanced duration 

claims also apply to standard 

(effectiveness) antiperspirant drug 

products.

B. Labeling Questions

In addition to data demonstrating an 

enhanced duration claim beyond 24 

hours, FDA requests comments on 

labeling related to products having such 

a claim. Currently, products 

demonstrating enhanced duration are 

allowed to contain a statement such as 

‘‘last 24 hours’’ (§ 350.50(b)(3) and 

(b)(5)) to inform consumers about the 

duration of effectiveness. However, 

there are no specific direction 

statements about how frequently to 

apply the product. The directions in 

§ 350.50(d) simply state ‘‘apply to 

underarms only.’’ For products 

demonstrating effectiveness for greater 

61150 Federal Register / Vol. 69, No. 199 / Friday, October 15, 2004 / Rules and Regulations 

than 24 hours (one day), additional or 

alternative labeling may be necessary. 

FDA would like comments regarding 

labeling, such as the following:

• How often to apply the product,

• The effect of bathing or showering 

before the duration of effect period 

ends, and

• Whether any other special labeling 

should apply to products with a 

duration of effect greater than 24 hours.

FDA also requests comments on 

whether there should be any limit on 

the enhanced duration claim and 

whether there are any potential safety 

issues if a product with enhanced 

duration of action is reapplied more 

frequently than directed (e.g., an 

antiperspirant labeled as providing 48 

hours of sweat protection applied every 

24 hours).

IV. Analysis of Impacts

The economic impact of the FM was 

discussed in the final rule (68 FR 34273 

at 34289). This partial stay of the 

labeling claims for enhanced duration in 

§ 350.50(b)(3) and (b)(5) does not change 

the economic impact on industry 

described in the final rule.

FDA has examined the impacts of this 

final rule under Executive Order 12866, 

the Regulatory Flexibility Act (5 U.S.C. 

601–612), and the Unfunded Mandates 

Reform Act of 1995 (2 U.S.C. 1501 et 

seq.). Executive Order 12866 directs 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

when regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). Under 

the Regulatory Flexibility Act, if a rule 

has a significant economic impact on a 

substantial number of small entities, an 

agency must analyze regulatory options 

that would minimize any significant 

impact of the rule on small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act requires that 

agencies prepare a written statement of 

anticipated costs and benefits before 

proposing any rule that may result in an 

expenditure in any one year by State, 

local, and tribal governments, in the 

aggregate, or by the private sector, of 

$100 million (adjusted annually for 

inflation). The current inflation adjusted 

statutory threshold is about $110 

million.

FDA concludes that this final rule is 

consistent with the regulatory 

philosophy and principles identified in 

the Executive order and in these two 

statutes. The final rule is not a 

significant regulatory action as defined 

by the Executive order and so is not 

subject to review under the Executive 

order. FDA has determined that the final 

rule does not have a significant 

economic impact on a substantial 

number of small entities. The Unfunded 

Mandates Reform Act does not require 

FDA to prepare a statement of costs and 

benefits for this final rule, because this 

final rule is not expected to result in any 

1-year expenditure that would exceed 

$100 million adjusted for inflation.

The purpose of this final rule is to 

stay the effective date of one part of the 

antiperspirant FM: The limitation of the 

enhanced duration claim to 24 hours 

(§ 350.50(b)(3) and (b)(5)). The partial 

stay will allow manufacturers who have 

supporting data to include greater than 

24 hour duration claims in the labeling 

of OTC antiperspirant drug products 

while FDA evaluates data to support 

such claims using FDA’s effectiveness 

test. FDA has learned that one 

manufacturer has approximately 40 

stockkeeping units (SKUs) and another 

manufacturer has several SKUs with 

labels indicating effectiveness for more 

than 24 hours. These manufacturers will 

not have to revise the existing 

‘‘enhanced duration’’ portion of their 

labeling when the FM becomes effective 

on December 9, 2004. Accordingly, FDA 

certifies that this final rule will not have 

a significant economic impact on a 

substantial number of small entities. 

Therefore, under the Regulatory 

Flexibility Act, no further analysis is 

required.

V. Paperwork Reduction

This final 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.

VI. Environmental Impact

FDA has 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.

VII. Federalism

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the rule does not 

contain policies that have substantial 

direct effects on the States, on the 

relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Accordingly, FDA 

has concluded that the rule does not 

contain policies that have federalism 

implications as defined in the Executive 

order and, consequently, a federalism 

summary impact statement is not 

required.

VIII. Request for Comments

Interested persons may submit written 

or electronic comments regarding this 

rule to the Division of Dockets 

Management (see ADDRESSES). Three 

copies of all written comments are to be 

submitted. Individuals submitting 

written comments or anyone submitting 

electronic comments may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document and may be accompanied by 

a supporting memorandum or brief. 

Received comments may be seen in the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday.

IX. References

The following references are on 

display in the Division of Dockets 

Management (see ADDRESSES) under 

Docket No. 1978N–0064 and may be 

seen by interested persons between 9 

a.m. and 4 p.m., Monday through 

Friday.

1. Comment No. PRC1.

2. Comment No. PRC2.

3. Comment No. SUP4.

4. Comment No. C54.

X. Authority

This final rule (partial stay) is issued 

under sections 201, 501, 502, 503, 505, 

510, and 701 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 321, 351, 

352, 353, 355, 360, and 371) and under 

authority delegated to the Commissioner 

of Food and Drugs.

Dated: October 6, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–23106 Filed 10–14–04; 8:45 am]

BILLING CODE 4160–01–S

PENSION BENEFIT GUARANTY 

CORPORATION 

29 CFR Parts 4022 and 4044 

Benefits Payable in Terminated SingleEmployer Plans; Allocation of Assets 

in Single-Employer Plans; Interest 

Assumptions for Valuing and Paying 

Benefits

AGENCY: Pension Benefit Guaranty 

Corporation.

ACTION: Final rule.