This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

63482

Vol. 69, No. 211

Tuesday, November 2, 2004

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 341

[Docket No. 1976N–0052N]

RIN 0910–AF34

Cold, Cough, Allergy, Bronchodilator, 

and Antiasthmatic Drug Products for 

Over-the-Counter Human Use; 

Proposed Amendment of Monograph 

for Over-the-Counter Nasal 

Decongestant Drug Products

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

amend the final monograph (FM) for 

over-the-counter (OTC) nasal 

decongestant drug products (drug 

products used to relieve nasal 

congestion due to a cold, hay fever, or 

other upper respiratory allergies) to add 

phenylephrine bitartrate as generally 

recognized as safe and effective 

(GRASE) when used in an effervescent 

tablet. An effervescent tablet is intended 

to be dissolved in water before taking by 

mouth. This proposal is part of FDA’s 

ongoing review of OTC drug products.

DATES: Submit written or electronic 

comments and comments on FDA’s 

economic impact determination by 

January 31, 2005. Please see section X 

of this document for the effective date 

of any final rule that may publish based 

on this proposal.

ADDRESSES: You may submit comments, 

identified by Docket No. 1976N–0052N 

and/or RIN number 0910–AF34, 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 the instructions for submitting 

comments on the agency Web site.

• E-mail: fdadockets@oc.fda.gov. 

Include Docket No. 1976N–0052N and/

or RIN number 0910–AF34 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. 1976N–0052N or Regulatory 

Information Number 0910–AF34 (RIN) 

for this rulemaking. All comments 

received will be posted without change 

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

default.htm, 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/ohrms/dockets/

default.htm and insert the docket 

number(s), 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:

Houda Mahayni, 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

A. Advance Notice of Proposed 

Rulemaking (ANPRM)

1. OTC Cough-Cold Drug Products

In the Federal Register of September 

9, 1976 (41 FR 38312), FDA published 

the report of the Advisory Review Panel 

on OTC Cold, Cough, Allergy, 

Bronchodilator, and Antiasthmatic Drug 

Products (Cough-Cold Panel). That 

Panel reviewed oral and topical nasal 

decongestant drug products and found 

phenylephrine hydrochloride to be a 

safe and effective ingredient for OTC 

use (41 FR 38312 at 38399 and 38400). 

The Cough-Cold Panel did not evaluate 

phenylephrine bitartrate.

2. OTC Oral Health Care Drug Products

In the Federal Register of May 25, 

1982 (47 FR 22760), FDA published the 

report of the Advisory Review Panel on 

OTC Oral Cavity Drug Products (Oral 

Cavity Panel). That Panel reviewed the 

safety and effectiveness of two oral 

nasal decongestant ingredients, 

phenylephrine hydrochloride and 

phenylpropanolamine hydrochloride (in 

lozenge form), and classified these 

ingredients as Category III (more data 

needed) (47 FR 22760 at 22911 through 

22914). The Oral Cavity Panel did not 

evaluate phenylephrine bitartrate.

B. Tentative Final Monograph (TFM)

1. OTC Cough-Cold Drug Products

In the Federal Register of January 15, 

1985 (50 FR 2220), FDA published the 

TFM for OTC nasal decongestant drug 

products. The TFM proposed 

phenylephrine hydrochloride as a 

monograph ingredient but did not 

address phenylephrine bitartrate.

2. OTC Oral Health Care Drug Products

In the Federal Register of January 27, 

1988 (53 FR 2436), FDA published the 

TFM for OTC oral health care 

(anesthetic/analgesic, astringent, 

debriding agent/oral wound cleanser, 

and demulcent) drug products. FDA 

referred the data on the oral nasal 

decongestant ingredients phenylephrine 

hydrochloride and 

phenylpropanolamine hydrochloride to 

the rulemaking for OTC nasal 

decongestant drug products because that 

was the primary rulemaking for these 

ingredients (53 FR 2436 at 2448 and 

2449).

C. Final Monograph (FM)

1. OTC Cough-Cold Drug Products

In the Federal Register of August 23, 

1994 (59 FR 43386), FDA published the 

FM for OTC nasal decongestant drug 

products. The monograph included 

phenylephrine hydrochloride as GRASE 

for oral and topical use as a nasal 

decongestant (§ 341.20(a) and (b)(8) (21 

CFR 341.20(a) and (b)(8))). FDA 

acknowledged that phenylephedrine 

bitartrate was submitted as an oral nasal 

decongestant active ingredient in an 

effervescent combination cold tablets for 

OTC use. FDA noted that the ingredient 

was not reviewed by the Cough-Cold 

Panel or included in its report, or 

addressed in the TFM for OTC nasal 

Federal Register / Vol. 69, No. 211 / Tuesday, November 2, 2004 / Proposed Rules 63483

decongestant drug products (59 FR 

43386 at 43394 and 43395). FDA 

reviewed data on phenylephedrine 

bitartrate submitted in a comment and 

concluded that the data were inadequate 

to demonstrate the safety and 

effectiveness of phenylephrine bitartrate 

as an OTC oral nasal decongestant 

ingredient. Consequently, this 

ingredient was not included in the FM.

2. OTC Oral Health Care Drug Products

FDA has not published an FM for 

these products.

II. Citizen Petition

A manufacturer submitted a citizen 

petition (Ref. 1) requesting FDA to 

amend the OTC nasal decongestant FM 

to include the ingredient phenylephrine 

bitartrate as GRASE in an effervescent 

tablet. The manufacturer stated:

• Domestic and international 

marketing experiences meet FDA’s 

material time and extent criteria for 

inclusion in an OTC drug monograph.

• In vitro and in vivo studies 

demonstrate comparability of 

phenylephrine bitartrate with 

phenylephrine hydrochloride, an 

approved monograph active ingredient.

• Phenylephrine bitartrate would 

provide consumers a greater choice in 

combination nasal decongestant/

analgesic cough-cold formulations.

The manufacturer requested GRASE 

status for phenylephrine bitartrate for 

use as a single ingredient or in 

combination with any monograph 

cough-cold active ingredient(s) when 

delivered in an effervescent tablet.

III. FDA’s Comments on the Citizen 

Petition

A. Marketing History

According to the manufacturer, 

consumers have used phenylephrine 

hydrochloride and bitartrate 

domestically and globally as a nasal 

decongestant for decades. In terms of 

domestic marketing experience, the 

following drug products containing 

phenylephrine bitartrate have been 

marketed in the United States: (1) An 

effervescent product containing aspirin, 

chlorpheniramine maleate, and 

phenylephrine bitartrate marketed OTC 

from 1968 to 1976, before being 

voluntarily discontinued by its 

manufacturer, and (2) an inhalation 

product containing isoproterenol 

hydrochloride and phenylephrine 

bitartrate marketed by prescription and 

later discontinued. Phenylephrine 

bitartrate containing products have been 

marketed outside the United States 

(Central America, Mexico, Australia, 

and Spain) since 1978. As of 2002, a 

total of 1.16 billion tablets have been 

distributed in these countries (Ref. 1).

Products containing bitartrate are 

presently sold by prescription in the 

United States as a salt of hydrocodone, 

dihydrocodone, and dihydrocodeine. 

Phenylephrine bitartrate is similar to 

phenylephrine hydrochloride, which is 

currently included as an oral nasal 

decongestant active ingredient in 

§ 341.20(a)(1). Both phenylephrine salts 

have the same pharmacologic activity 

and similar side effects. FDA is aware 

that phenylephrine bitratrate 

effervescent tablets were marketed in 

the United States in the 1960s and 

1970s and had a similar use and adverse 

reaction profile as products containing 

phenylephrine hydrochloride. The 

citizen petition provides sufficient 

information of marketing outside the 

United States since 1978 to allow FDA 

to determine that phenylephrine 

bitartrate as a nasal decongestant has 

been marketed to a material time and to 

a material extent. In addition, the 

citizen petition contains recent data 

demonstration that the phenylephrine 

bitartrate salt is bioavailable and 

comparable to the phenylephrine 

hydrochloride salt.

B. Safety and Effectiveness

1. Review of Adverse Event Databases 

(AEDs)

The manufacturer conducted a safety 

review of the FDA and World Health 

Organization’s (WHO) AEDs concerning 

phenylephrine bitartrate for the period 

from 1969 to 1997. The review included 

all dosage forms of phenylephrine but 

was nonspecific for the phenylephrine 

salt (e.g., hydrochloride or bitartrate). 

The review identified 22 reports for 

phenylephrine bitartrate out of 

approximately 900 reports for 

phenylephrine administered orally. 

There were five reports of ‘‘no drug 

effect’’, two reports of nervousness, and 

15 different single events reported such 

as rash, vomiting, diarrhea, and 

insomnia. The manufacturer 

commented that causality and 

preexisting conditions in the 22 

reported subjects could not be 

established from the available data. The 

manufacturer noted that:

• The FDA database does not indicate 

the relationship of adverse events or 

preexisting medical conditions of 

consumers to the administration of 

phenylephrine.

• The WHO database revealed five 

different single event reports for 

products containing phenylephrine 

bitartrate as an active ingredient.

• Reports provided by the 

manufacturer’s affiliate from other 

countries in which phenylephrine 

bitartrate products are marketed 

provided no information on adverse 

events relative to phenylephrine 

bitartrate.

FDA finds these data suggest that 

there are no significant safety concerns 

reported from the use of phenylephrine 

bitartrate in the countries where it is 

currently used. Safety information from 

various U.S. databases is not available 

specifically for phenylephrine bitartrate 

because it has not been marketed for the 

past 30 years. Safety information from 

U.S. databases indicate that 

phenylephrine hydrochloride is safe for 

OTC use within the label warnings in 

§ 341.80(c)(1) (21 CFR 341.80(c)(1)). 

Based on their similar pharmacologic 

activity and side effects, FDA has 

determined that both phenylephrine 

salts are safe for OTC use.

2. Pharmacokinetic Study

In a meeting held on February 15, 

2002 (Ref. 2), FDA suggested that the 

manufacturer conduct a bioequivalence 

study. FDA recommended that the 

manufacturer follow FDA’s Guidance 

for Industry entitled ‘‘Bioavailability 

and Bioequivalence Studies for Orally 

Administered Drug Products General 

Considerations’’ (the Guidance) (Ref. 3). 

The Guidance describes a single-dose 

pharmacokinetic study of both 

immediate and modified release drug 

products to demonstrate bioequivalence. 

FDA generally considers a single-dose 

study to be more sensitive than a 

multiple-dose study in assessing the 

release of the drug substance from the 

drug product into the systemic 

circulation. Further, if a multiple-dose 

study design is necessary, the Guidance 

recommends performing appropriate 

dosage administration and sampling to 

document that ‘‘steady-state’’ is 

attained. At steady-state, the rate of drug 

leaving the body is equal to the rate of 

drug entering the body.

The manufacturer submitted an openlabel, four-way crossover, multiple-dose 

study in healthy volunteers to evaluate 

the pharmacokinetic profiles of the 

following equivalent phenylephrine 

doses of phenylephrine hydrochloride 

and phenylephrine bitartrate in two 

different dosage forms and different 

weights because of the different salts 

forms:

• An effervescent phenylephrine 

hydrochloride 10 milligram (mg) tablet

• An effervescent phenylephrine 

bitartrate 15.6 mg tablet

63484 Federal Register / Vol. 69, No. 211 / Tuesday, November 2, 2004 / Proposed Rules 

1Encapsulated is a capsule dosage form that was 

termed ‘‘encapsulated’’ by the manufacturer in this 

study.

• an encapsulated1 phenylephrine 

hydrochloride 10 mg capsule

• an encapsulated phenylephrine 

bitartrate 15.6 mg capsule

Twenty-five subjects completed the 

study and were considered evaluable for 

the pharmacokinetic analysis. All 

subjects were treated with four oral 

doses of phenylephrine over a 12-hour 

period. The first dose was administered 

at 7 a.m. Subsequent doses were 

administered 4, 8, and 12 hours later. 

The analysis provided the mean ratio 

and 90 percent confidence interval of 

the derived pharmacokinetic 

parameters, area under the 

concentration-time curve (AUC) and 

maximum plasma concentration (Cmax), 

after single dose and at steady-state for 

each treatment.

3. FDA’s Evaluation of the 

Pharmacokinetic Study

Bioequivalence may be determined 

from a multiple-dose study only after a 

steady-state plasma drug level has been 

reached. The time needed to reach the 

steady-state plasma level is related to 

the elimination half-life of the drug. It 

takes approximately 6.6 half-lives to 

reach 99 percent of steady-state plasma 

level. If steady-state blood levels are 

going to be used for the determinations 

of bioequivalence, both drug products 

must be administered to steady-state. 

Based on the comparison of the 

pharmacokinetic parameters obtained, 

the bioequivalence or lack of 

bioequivalence may be determined.

The manufacturer did not conduct a 

single-dose pharmacokinetic study. The 

manufacturer performed a study in 

which four doses of the phenylephrine 

formulations were administered every 4 

hours in 1 day. The elimination half-life 

of phenylephrine is between 2 and 3 

hours. Therefore, it takes between 13.2 

(2 x 6.6) and 19.8 (3 x 6.6) hours to 

reach steady-state, at which time blood 

levels could be obtained to compare and 

determine bioequivalence. Thus, the 

study was not designed to achieve 

steady-state, nor did the manufacturer 

document that steady-state was reached, 

which is necessary to establish 

bioequivalence. Therefore, the study can 

only demonstrate comparable 

bioavailability or similarity, but not 

bioequivalence. Independent scientific 

study, did not allow enough time 

between doses.

Table 1 of this document provides a 

summary of total phenylephrine 

pharmacokinetic parameters derived 

from the first-dose data. First-dose data 

are being considered because attainment 

of steady-state was not documented and 

because it is the most robust observation 

of the data.

TABLE 1.—SUMMARY OF TOTAL PHENYLEPHRINE PHARMACOKINETIC PARAMETERS-DERIVED FROM FIRST-DOSE DATAMEAN RATIO, 90 PERCENT CONFIDENCE INTERVAL (CI), AND SIGNIFICANCE (P=0.05) (N=25) 

Treatment Comparison 

Actual AUCt

Ratio

CI

p-value

log AUCt

Ratio

CI

p-value

Actual 

CmaxRatio

CI

p-value

log Cmax Ratio

CI

p-value

PEB–E1 vs. PEH–E2 0.98

0.93–1.03

0.4298

1.00

0.99–1.00

0.5077

1.00

0.93–1.07

0.991

1.00

0.99–1.01

0.8642

PEB–C3 vs. PEH–C4 0.91

0.87–0.96

0.0050

0.98

0.98–0.99

0.0020

0.90

0.85–0.97

0.0137

0.98

0.97–0.99

0.0062

1Phenylephrine bitartrate in an effervescent tablet.

2Phenylephrine hydrochloride in an effervescent tablet.

3Phenylephrine bitartrate in a capsule.

4Phenylephrine hydrochloride in a capsule.

Table 1 of this document shows that, 

for the effervescent tablet, the mean 

ratio (log transformed) for both the Cmax

and AUC is 1.00 when comparing 

phenylephrine hydrochloride to 

phenylephrine bitartrate. The actual 

ratios range from 0.98 to 1.0. Therefore, 

the rate and extent of absorption after 

the first-dose of the phenylephrine 

bitartrate effervescent tablet are 

considered similar to those of the 

phenylephrine hydrochloride 

effervescent tablet.

Although the manufacturer did not 

perform a single-dose or a multiple-dose 

study (to steady-state), the similarity in 

the rate and extent of absorption of 

phenylephrine hydrochloride and 

phenylephrine bitartrate in the 

effervescent tablets allows FDA to 

conclude that the bioavailability of the 

phenylephrine salts in the effervescent 

tablets is comparable.

Table 1 of this document shows that, 

for the encapsulated formulation, the 

actual mean ratio for AUC and Cmax are 

0.91 and 0.90 for AUC and Cmax

respectively. Because this study was not 

of optimal design, FDA has concerns 

about the plasma concentration-time 

curve that is not available because the 

second dose was administered. FDA 

cannot conclude that the in vivo 

performance of the products are similar 

because of the magnitude of the 

difference of the actual mean ratios of 

0.90 and 0.91 from 1.0. The 

encapsulated capsule is bioavailable but 

not bioequivalent to the effervescent 

tablet.

IV. FDA’s Tentative Conclusions

A. Single Ingredient Products

FDA has tentatively determined that 

phenylephrine bitartrate has been 

marketed to a material extent and for a 

material time as a nasal decongestant 

with no indication of safety concerns. 

Based on the ingredient’s marketing 

history, absence of safety concerns, and 

additional data provided in the 

manufacturer’s citizen petition, FDA has 

determined that the pharmacokinetic 

study is acceptable in lieu of a clinical 

trial because of the similarity in the 

bioavailability of the two effervescent 

Federal Register / Vol. 69, No. 211 / Tuesday, November 2, 2004 / Proposed Rules 63485

tablets. Accordingly, FDA acknowledges 

that the two salts of phenylephrine 

could be used in the effervescent tablets 

interchangeably without any clinically 

significant impact on the performance of 

the formulations studied. FDA is 

proposing that phenylephrine bitartrate 

in an effervescent tablet be GRASE for 

use as an OTC oral nasal decongestant. 

Accordingly, FDA is proposing to 

amend § 341.20(a)(4) of the FM for OTC 

nasal decongestant drug products to 

include phenylephrine bitartrate in an 

effervescent tablet. However, additional 

pharmacokinetic data are needed to 

include the phenylephrine bitartrate 

capsule formulation in the OTC nasal 

decongestant FM.

B. Combination Products

The combination of single 

antihistamine, oral nasal decongestant, 

and analgesic-antipyretic active 

ingredients is included in 21 CFR 

341.40(c) of the Cough-Cold FM. FDA is 

proposing to include in the FM the 

combination of chlorpheniramine 

maleate (antihistamine), phenylephrine 

bitartrate (oral nasal decongestant), and 

aspirin (analgesic-antipyretic) in an 

effervescent tablet. FDA is including 

only this specific combination product 

for the following reasons:

• This is the only combination 

containing phenylephrine bitartrate that 

has an OTC marketing history in the 

United States. It was marketed from 

1968 to 1976.

• The bitartrate salt form of the OTC 

nasal decongestant 

phenylpropanolamine was reviewed by 

the Cough-Cold Panel and 

recommended for monograph status as 

GRASE (41 FR 38312 at 38400 and 

38401).

• The rate and extent of absorption of 

phenylephrine bitartrate effervescent 

tablet after the first-dose and at steadystate were similar to those of 

phenylephrine hydrochloride 

effervescent tablet. Thus, the two 

phenylephrine salts appear to have 

comparable bioavailability. A drug-drug 

interaction study is not necessary for the 

combination of chlorpheniramine 

maleate, phenylephrine bitartrate, and 

aspirin.

FDA does not have data on any other 

combination products to include them 

in the FM at this time. FDA is not aware 

of other combination products 

containing phenylephrine bitartrate that 

may have been marketed. To market any 

other combination product containing 

phenylephrine bitartrate, manufacturers 

will need to submit a new drug 

application deviation (21 CFR 330.11).

C. Monograph Labeling

FDA is proposing the same uses and 

warnings for phenylephrine bitartrate as 

appear in § 341.80(b) and (c)(1) for 

phenylephrine hydrochloride because 

these are salt of the same ingredient. 

Based on historical marketing in the 

United States, more current marketing 

in foreign countries, and the 

pharmacokinetic study, FDA is 

proposing the following doses:

• Adults and children 12 years of age 

and over: 15.6 milligrams every 4 hours, 

not to exceed 62.4 milligrams in 24 

hours

• Children 6 to under 12 years of age: 

7.8 milligrams every 4 hours, not to 

exceed 31.2 milligrams in 24 hours

• Children under 6 years of age: ask 

a doctor

FDA proposes that manufacturers 

include in their product labeling 

information on the number of tablets 

and the quantity of water the tablets are 

to be dissolved in prior to 

administration.

FDA is also proposing to define 

effervescent tablet in 21 CFR 341.3 to 

state:

Effervescent tablet. A tablet intended to be 

dissolved in water before administration. It 

contains, in addition to the active 

ingredient(s), mixtures of acids (citric acid, 

tartaric acid) and sodium bicarbonate, which 

release carbon dioxide when dissolved in 

water.

D. Statement About Warnings

Mandating warnings in an OTC drug 

monograph does not require a finding 

that any or all of the OTC drug products 

covered by the monograph actually 

caused an adverse event, and FDA does 

not so find. Nor does FDA’s requirement 

of warnings repudiate the prior OTC 

drug monographs and monograph 

rulemakings under which the affected 

drug products have been lawfully 

marketed. Rather, as a consumer 

protection agency, FDA has determined 

that warnings are necessary to ensure 

that these OTC drug products continue 

to be safe and effective for their labeled 

indications under ordinary conditions 

of use as those terms are defined in the 

Federal Food, Drug, and Cosmetic Act. 

This judgment balances the benefits of 

these drug products against their 

potential risks. (See 21 CFR 330.10(a).)

FDA’s decision to act in this instance 

need not meet the standard of proof 

required to prevail in a private tort 

action (Glastetter v. Novartis 

Pharmaceuticals Corp., 252 F.3d 986, 

991 (8th Cir. 2001)). To mandate 

warnings, or take similar regulatory 

action, FDA need not show, nor do we 

allege, actual causation. For an 

expanded discussion of case law 

supporting FDA’s authority to require 

such warnings, see Labeling of 

Diphenhydramine-Containing Drug 

Products for Over-the-Counter Human 

Use, Final Rule, 67 FR 72555 (December 

6, 2002).

E. USP Monograph

FDA’s policy is that for an active 

ingredient to be included in an OTC 

drug FM, it is necessary to have publicly 

available chemical information that can 

be used by all manufacturers to 

determine that the ingredient is 

appropriate for use in their products. 

(See the Federal Register of April 3, 

1989 (54 FR 13480 at 13486), and June 

20, 1990 (55 FR 25204 at 25215).) 

Because phenylephrine bitartrate is not 

currently standardized and 

characterized for quality and purity in 

the official compendium, i.e., the 

United States Pharmacopoeia (USP)-

National Formulary (NF), it will not be 

included in the FM until such 

information is available. A proposed 

compendial monograph for 

phenylephrine bitartrate was published 

in the Pharmacopeial Forum for MayJune 2004 (Ref. 4). When a final 

compendial monograph is published in 

the USP-NF, FDA intends to finalize its 

proposal to include phenylephrine 

bitartrate in an effervescent tablet in the 

FM. Interim marketing of phenylephrine 

bitartrate in an effervescent tablet before 

an amendment to include this 

ingredient in the FM is finalized is not 

allowed and may subject any such 

products to regulatory action.

V. Analysis of Impacts

FDA has 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). Under the 

Regulatory Flexibility Act, if the 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 of 1995 requires 

that agencies prepare a written 

statement, which includes and 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

63486 Federal Register / Vol. 69, No. 211 / Tuesday, November 2, 2004 / Proposed Rules 

includes any Federal mandate that may 

result in an expenditure in any one year 

by State, local, and tribal governments, 

in the aggregate, or by private sector, of 

$100,000,000 (adjusted annually for 

inflation) in any one year.’’

FDA believes that this proposed rule 

is consistent with the principles set out 

in Executive Order 12866 and in these 

two statutes. This proposed rule is not 

a significant regulatory action as defined 

by the Executive order and so is not 

subject to review under the Executive 

order. As discussed in this section, FDA 

has determined that this proposed rule, 

if finalized, will not have a significant 

economic impact on a substantial 

number of small entities. The Unfunded 

Mandates Reform Act of 1995 does not 

require FDA to prepare a statement of 

costs and benefits for this proposed rule, 

because the proposed rule is not 

expected to result in any 1-year 

expenditure that would exceed $100 

million adjusted for inflation. The 

current inflation adjusted statutory 

threshold is about $110 million.

The purpose of this proposed rule is 

to include phenylephrine bitartrate in 

the monograph for OTC nasal 

decongestant drug products. This 

proposal, when finalized, would allow 

manufacturers who market products 

containing this ingredient in foreign 

countries and manufacturers who would 

like to market products containing this 

ingredient in the United States to enter 

the market place under the OTC drug 

monograph instead of a new drug 

application (NDA). Cost savings will 

occur from marketing without an NDA.

Marketing a new OTC drug product 

containing phenylephrine bitartrate is 

optional for any interested 

manufacturer. The costs would involve 

the standard startup costs associated 

with marketing any new product under 

an OTC drug monograph. Manufacturers 

will not incur any costs determining 

how to state the product’s labeling 

because the monograph amendment 

(and any eventual final rule) will 

provide that information. Any final rule 

that issues based on this proposal will 

not be expected to require any new 

reporting and recordkeeping activities. 

Therefore, no additional professional 

skills would be needed.

FDA considered but rejected several 

alternatives: (1) Not including 

phenylephrine bitartrate in the 

monograph, (2) allowing other 

combinations, and (3) allowing interim 

marketing. FDA rejected the first 

alternative because it considers the data 

presented supportive of monograph 

status. FDA rejected the second 

alternative because it has no data to 

support other combinations at this time. 

FDA rejected the third alternative 

because there currently is no USP 

monograph for this ingredient. FDA 

considers it inappropriate to allow 

interim marketing until there are 

uniform standards for the ingredient in 

an official compendial monograph that 

all manufacturers can follow, and FDA 

publishes a notice in the Federal 

Register to allow interim marketing to 

begin.

This analysis shows that FDA has 

considered the burden to small entities. 

FDA does not consider an exemption for 

small entities necessary because those 

manufacturers can enter the market 

place like larger entities anytime after 

this proposal is finalized. Therefore, 

FDA certifies that this proposed rule 

will not have a significant economic 

impact on a substantial number of small 

entities. No further analysis is required 

under the Regulatory Flexibility Act (5 

U.S.C. 605(b)).

VI. Paperwork Reduction Act of 1995

FDA tentatively concludes that the 

proposed labeling requirements in this 

document are not subject to review by 

the Office of Management and Budget 

because they do not constitute a 

‘‘collection of information’’ under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). Rather, the 

monograph labeling is a ‘‘public 

disclosure of information originally 

supplied by the Federal government to 

the recipient for the purpose of 

disclosure to the public’’ (5 CFR 

1320.3(c)(2)).

VII. 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.

VIII. Federalism

FDA has analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. FDA 

has determined that the proposed 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 

tentatively concludes that the proposed 

rule does not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

has not been prepared.

IX. Comments

FDA is providing a period of 90 days 

for interested persons to submit written 

or electronic comments on the proposed 

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.

X. Proposed Effective Date

FDA is proposing that any final rule 

that may issue based on this proposal 

become effective 30 days after its date 

of publication in the Federal Register.

XI. References

The following references are on 

display in the Division of Dockets 

Management (see ADDRESSES) under 

Docket No. 1976N–0052N and may be 

seen by interested persons between 9 

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

Friday.

1. Comment No. CP18.

2. Comment No. MM9.

3. FDA ‘‘Guidance for Industry, 

Bioavailability and Bioequivalence Studies 

for Orally Administered Drug Products–

General Considerations,’’ October 2000.

4. ‘‘Phenylephrine Bitartrate’’ in 

Pharmacopeial Forum, The United States 

Pharmacopeial Convention, Inc., Rockville, 

MD, 30(3):923–924, May-June 2004.

List of Subjects in 21 CFR Part 341

Labeling, Over-the-counter drugs.

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 341 be amended as follows:

PART 341—COLD, COUGH, ALLERGY, 

BRONCHODILATOR, AND 

ANTIASTHMATIC DRUG PRODUCTS 

FOR OVER–THE–COUNTER HUMAN 

USE

1. The authority citation for 21 CFR 

part 341 continues to read as follows:

Authority: 21 U.S.C. 321, 351, 352, 353, 

355, 360, 371.

2. Section 341.3 is amended by 

adding paragraph (i) to read as follows:

§ 341.3 Definitions.

* * * * *

(i) Effervescent tablet. A tablet 

intended to be dissolved in water before 

Federal Register / Vol. 69, No. 211 / Tuesday, November 2, 2004 / Proposed Rules 63487

administration. It contains, in addition 

to the active ingredient(s), mixtures of 

acids (citric acid, tartaric acid) and 

sodium bicarbonate, which release 

carbon dioxide when dissolved in 

water.

3. Section 341.20 is amended by 

adding paragraph (a)(4) to read as 

follows:

§ 341.20 Nasal decongestant active 

ingredients.

* * * * *

(a) * * *

(4) Phenylephrine bitartrate in an 

effervescent tablet.

* * * * *

4. Section 341.40 is amended by 

revising paragraphs (b), (c), (e), (g), (i), 

(j), (m), (n), (p), (q), (r), (s), (t), (x), (y), 

(aa), and (bb) and by adding paragraph 

(cc) to read as follows:

§ 341.40 Permitted combinations of active 

ingredients.

* * * * *

(b) Any single antihistamine active 

ingredient identified in § 341.12 may be 

combined with any single oral nasal 

decongestant active ingredient 

identified in § 341.20(a)(1), (a)(2), and 

(a)(3) provided that the product is 

labeled according to § 341.85.

(c) Any single antihistamine active 

ingredient identified in § 341.12 may be 

combined with any single oral nasal 

decongestant active ingredient 

identified in § 341.20(a)(1), (a)(2), and 

(a)(3) and any generally recognized as 

safe and effective single analgesicantipyretic active ingredient, or any 

combination of acetaminophen with 

other analgesic-antipyretic active 

ingredients, or any aspirin and antacid 

combination provided that the product 

is labeled according to § 341.85.

* * * * *

(e) Any single antihistamine active 

ingredient identified in § 341.12(a) 

through (e) and (h) through (m) may be 

combined with any single oral 

antitussive active ingredient identified 

in § 341.14(a)(1) through (a)(4) and any 

single oral nasal decongestant active 

ingredient identified in § 341.20(a)(1), 

(a)(2), and (a)(3) provided that the 

product is labeled according to 

§ 341.85(c)(4). Diphenhydramine citrate 

in §§ 341.12(f) and 341.14(a)(5) or 

diphenhydramine hydrochloride in 

§§ 341.12(g) and 341.14(a)(6) may be 

both the antihistamine and the 

antitussive active ingredient provided 

that the product is labeled according to 

§ 341.70(a).

* * * * *

(g) Any single antihistamine active 

ingredient identified in § 341.12(a) 

through (e) or (h) through (m) may be 

combined with any single oral 

antitussive active ingredient identified 

in § 341.14(a)(1) through (a)(4) and any 

single oral nasal decongestant active 

ingredient identified in § 341.20(a)(1), 

(a)(2), or (a)(3) and any generally 

recognized as safe and effective single 

analgesic-antipyretic active ingredient, 

or any combination of acetaminophen 

with other analgesic-antipyretic active 

ingredients, or any aspirin and antacid 

combination provided that the product 

is labeled according to § 341.85(c)(4). 

Diphenhydramine citrate in §§ 341.12(f) 

and 341.14(a)(5) or diphenhydramine 

hydrochloride in §§ 341.12(g) and 

341.14(a)(6) may be both the 

antihistamine and the antitussive active 

ingredient provided that the product is 

labeled according to § 341.70(a).

* * * * *

(i) Any single oral antitussive active 

ingredient identified in § 341.14(a) may 

be combined with any single oral nasal 

decongestant active ingredient 

identified in § 341.20(a)(1), (a)(2), or 

(a)(3) provided that the product is 

labeled according to § 341.85.

(j) Any single oral antitussive active 

ingredient identified in § 341.14(a)(1) 

through (a)(4) may be combined with 

any single oral nasal decongestant active 

ingredient identified in § 341.20(a)(1), 

(a)(2), or (a)(3) and any single 

expectorant active ingredient identified 

in § 341.18 provided that the product is 

labeled according to § 341.85.

* * * * *

(m) Any single oral antitussive active 

ingredient identified in § 341.14(a) may 

be combined with any single oral nasal 

decongestant active ingredient 

identified in § 341.20(a)(1), (a)(2), or 

(a)(3) and any generally recognized as 

safe and effective single analgesicantipyretic active ingredient, or any 

combination of acetaminophen with 

other analgesic-antipyretic active 

ingredients, or any aspirin and antacid 

combination provided that the product 

is labeled according to § 341.85.

(n) Any single oral antitussive active 

ingredient identified in § 341.14(a)(1) 

through (a)(4) may be combined with 

any single oral nasal decongestant active 

ingredient identified in § 341.20(a)(1), 

(a)(2), or (a)(3) and any single 

expectorant active ingredient identified 

in § 341.18 and any generally 

recognized as safe and effective single 

analgesic-antipyretic active ingredient, 

or any combination of acetaminophen 

with other analgesic-antipyretic active 

ingredients, or any aspirin and antacid 

combination provided that the product 

is labeled according to § 341.85.

* * * * *

(p) Any single expectorant active 

ingredient identified in § 341.18 may be 

combined with any single oral nasal 

decongestant active ingredient 

identified in § 341.20(a)(1), (a)(2), or 

(a)(3) provided that the product is 

labeled according to § 341.85.

(q) Any single expectorant active 

ingredient identified in § 341.18 may be 

combined with any single oral nasal 

decongestant active ingredient 

identified in § 341.20(a)(1), (a)(2), or 

(a)(3) and any generally recognized as 

safe and effective single analgesicantipyretic active ingredient, or any 

combination of acetaminophen with 

other analgesic-antipyretic active 

ingredients, or any aspirin and antacid 

combination provided that the product 

is labeled according to § 341.85.

(r) Any single oral nasal decongestant 

active ingredient identified in 

§ 341.20(a)(1), (a)(2), or (a)(3) may be 

combined with any generally recognized 

as safe and effective single analgesicantipyretic active ingredient, or any 

combination of acetaminophen with 

other analgesic-antipyretic active 

ingredients, or any aspirin and antacid 

combination provided that the product 

is labeled according to § 341.85.

(s) Any single oral nasal decongestant 

active ingredient identified in 

§ 341.20(a)(1), (a)(2), or (a)(3) may be 

combined with any generally recognized 

as safe and effective single oral 

anesthetic/analgesic active ingredient, 

or any combination of anesthetic/

analgesic active ingredients provided 

that the product is available in either a 

liquid (to be swallowed) or a solid 

dosage form (to be dissolved in the 

mouth and swallowed) and provided 

that the product is labeled according to 

§ 341.85.

(t) Any single oral nasal decongestant 

active ingredient identified in 

§ 341.20(a)(1), (a)(2), or (a)(3) may be 

combined with any single antitussive 

active ingredient identified in 

§ 341.14(a) or (b)(2) and any generally 

recognized as safe and effective single 

oral anesthetic/analgesic active 

ingredient, or any combination of 

anesthetic/analgesic active ingredients 

provided that the product is available in 

either a liquid (to be swallowed) or a 

solid dosage form (to be dissolved in the 

mouth and swallowed) and provided 

that the product is labeled according to 

§ 341.85. If the combination contains a 

topical antitussive, the product must be 

formulated in a solid dosage form to be 

dissolved in the mouth.

* * * * *

(x) Any single oral nasal decongestant 

active ingredient identified in 

§ 341.20(a)(1), (a)(2), or (a)(3) may be 

63488 Federal Register / Vol. 69, No. 211 / Tuesday, November 2, 2004 / Proposed Rules 

combined with any generally recognized 

as safe and effective single oral 

demulcent active ingredient provided 

that the product is available in either a 

liquid (to be swallowed) or a solid 

dosage form (to be dissolved in the 

mouth and swallowed) and provided 

that the product is labeled according to 

§ 341.85.

(y) Any single antitussive active 

ingredient identified in § 341.14(a) or 

(b)(2) may be combined with any single 

oral nasal decongestant active 

ingredient identified in § 341.20(a)(1), 

(a)(2), or (a)(3) and any generally 

recognized as safe and effective single 

oral demulcent active ingredient 

provided that the product is available in 

either a liquid (to be swallowed) or a 

solid dosage form (to be dissolved in the 

mouth and swallowed) and provided 

that the product is labeled according to 

§ 341.85. If the combination contains a 

topical antitussive, the product must be 

formulated in a solid dosage form to be 

dissolved in the mouth.

* * * * *

(aa) Any single oral nasal 

decongestant active ingredient 

identified in § 341.20(a)(1), (a)(2), or 

(a)(3) may be combined with any 

generally recognized as safe and 

effective single oral anesthetic/analgesic 

active ingredient, or any combination of 

oral anesthetic/analgesic active 

ingredients and any generally 

recognized as safe and effective single 

oral demulcent active ingredient 

provided that the product is available in 

either a liquid (to be swallowed) or a 

solid dosage form (to be dissolved in the 

mouth and swallowed) and provided 

that the product is labeled according to 

§ 341.85.

(bb) Any single antitussive active 

ingredient identified in § 341.14(a) or 

(b)(2) may be combined with any single 

oral nasal decongestant active 

ingredient identified in § 341.20(a)(1), 

(a)(2), or (a)(3) and any generally 

recognized as safe and effective single 

oral anesthetic/analgesic active 

ingredient, or any combination of 

anesthetic/analgesic active ingredients 

and any generally recognized as safe 

and effective single oral demulcent 

active ingredient provided that the 

product is available in either a liquid (to 

be swallowed) or a solid dosage form (to 

be dissolved in the mouth and 

swallowed) and provided that the 

product is labeled according to § 341.85. 

If the combination contains a topical 

antitussive, the product must be 

formulated in a solid dosage form to be 

dissolved in the mouth.

(cc) Phenylephrine bitartrate 

identified in § 341.20(a)(4) may be 

combined with chlorpheniramine 

maleate identified in § 341.12(c) and 

aspirin provided the product is 

available only in an effervescent tablet 

and provided that the product is labeled 

according to § 341.85.

5. Section 341.80 is amended by 

revising the headings in paragraphs 

(c)(1)(i) and (c)(1)(ii), and by adding 

paragraph (d)(1)(iii) to read as follows:

§ 341.80 Labeling of nasal decongestant 

drug products.

* * * * *

(c) * * *

(1) Oral nasal decongestants—(i) For 

products containing phenylephrine 

hydrochloride, pseudoephedrine 

hydrochloride, pseudoephedrine sulfate, 

or phenylephrine bitartrate identified in 

§ 341.20(a)(1) through (a)(4) when 

labeled for adults. * * *

* * * * *

(ii) For products containing 

phenylephrine hydrochloride, 

pseudoephedrine hydrochloride, 

pseudoephedrine sulfate, or 

phenylephrine bitartrate identified in 

§ 341.20(a)(1) through (a)(4) when 

labeled for children under 12 years of 

age. * * *

* * * * *

(d) * * *

(1) * * *

(iii) For products containing 

phenylephrine bitartrate identified in 

§ 341.20(a)(4). Include information on 

the number of dosage units and the 

quantity of water the dosage units are to 

be dissolved in prior to administration 

as shown in the following table:

Age1 Dose1

adults and children 12 years of age and over 15.6 milligrams every 4 hours not to exceed 62.4 milligrams 

in 24 hours

children 6 to under 12 years of age 7.8 milligrams every 4 hours not to exceed 31.2 milligrams in 

24 hours

children under 6 years of age ask a doctor

1 Headings are not required to appear in the product’s labeling.

* * * * *

6. Section 341.85 is amended by 

revising the headings in paragraphs 

(a)(1), (b)(1), (b)(2), (b)(3), and (c)(3).

§ 341.85 Labeling of permitted 

combinations of active ingredients.

* * * * *

(a) * * *

(1) For permitted combinations 

identified in § 341.40(a), (c), (f), (g), (l), 

(m), (n), (o), (q), (r), and (cc) containing 

an analgesic-antipyretic active 

ingredient. * * *

* * * * *

(b) * * *

(1) For permitted combinations 

containing an analgesic-antipyretic 

active ingredient identified in 

§ 341.40(a), (c), (f), (g), (l), (m), (n), (o), 

(q), (r), and (cc) when labeled for relief 

of general cough-cold symptoms and/or 

the common cold. * * *

* * * * *

(2) For permitted combinations 

containing an analgesic-antipyretic 

active ingredient identified in 

§ 341.40(a), (c), (f), (g), (m), (q), (r), and 

(cc) when labeled for relief of hay fever/

allergic rhinitis and/or sinusitis 

symptoms. * * *

* * * * *

(3) For permitted combinations 

containing an oral analgesic-antipyretic 

active ingredient identified in 

§ 341.40(a), (c), (f), (g), (m), (q), (r), and 

(cc) when labeled for relief of general 

cough-cold symptoms and/or the 

common cold and for relief of hay fever/

allergic rhinitis and/or sinusitis 

symptoms.* * *

* * * * *

(c) * * *

Federal Register / Vol. 69, No. 211 / Tuesday, November 2, 2004 / Proposed Rules 63489

(3) For permitted combinations 

containing a nasal decongestant and an 

analgesic-antipyretic identified in 

§ 341.40(c), (g), (m), (n), (q), (r), and (cc). 

***

* * * * *

Dated: October 26, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–24423 Filed 11–1–04; 8:45 am]

BILLING CODE 4160–01–S

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 63

[GA–112L–2004–1–FRL–7832–8] 

Approval of Section 112(l) Authority for 

Hazardous Air Pollutants; Equivalency 

by Permit Provisions; National 

Emission Standards for Hazardous Air 

Pollutants From the Pulp and Paper 

Industry; State of Georgia

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: Pursuant to section 112(l) of 

the Clean Air Act (CAA), the Georgia 

Environmental Protection Division 

(GEPD) requested approval to 

implement and enforce State permit 

terms and conditions that substitute for 

the National Emission Standards for 

Hazardous Air Pollutants from the Pulp 

and Paper Industry. In the Rules section 

of this Federal Register, EPA is granting 

GEPD the authority to implement and 

enforce alternative requirements in the 

form of title V permit terms and 

conditions after EPA has approved the 

State’s alternative requirements. A 

detailed rationale for this approval is set 

forth in the direct final rule. If no 

significant, or adverse comments are 

received, no further activity is 

contemplated. If EPA receives 

significant, or adverse comments, the 

direct final rule will be withdrawn and 

all public comments received will be 

addressed in a subsequent final rule 

based on this rule. The EPA will not 

institute a second comment period on 

this document. Any parties interested in 

commenting on this document should 

do so at this time.

DATES: Written comments must be 

received on or before November 23, 

2004.

ADDRESSES: Comments may be 

submitted by mail to: Lee Page, Air 

Toxics Assessment and Implementation 

Section, Air Toxics and Monitoring 

Branch, Air, Pesticides and Toxics 

Management Division; U.S. 

Environmental Protection Agency 

Region 4; 61 Forsyth Street, SW., 

Atlanta, Georgia 30303–8960. Duplicate 

copies of all comments must also be 

submitted to Ron C. Methier, Chief, Air 

Protection Branch, Georgia 

Environmental Protection Division, 

4244 International Parkway, Suite 120, 

Atlanta, Georgia 30354. Comments may 

also be submitted electronically, or 

through hand delivery/courier. Please 

follow the detailed instructions 

described in the direct final rule, 

SUPPLEMENTARY INFORMATION section 

[part (I)(B)(1)(i) through (iii)] which is 

published in the Rules section of this 

Federal Register.

FOR FURTHER INFORMATION CONTACT: Lee 

Page, Air Toxics Assessment and 

Implementation Section, Air Toxics and 

Monitoring Branch, Air, Pesticides and 

Toxics Management Division, Region 4, 

U.S. Environmental Protection Agency, 

61 Forsyth Street, SW., Atlanta, Georgia 

30303–8960. The telephone number is 

(404) 562–9141. Mr. Page can also be 

reached via electronic mail at 

page.lee@epa.gov.

SUPPLEMENTARY INFORMATION: For 

additional information see the direct 

final rule which is published in the 

Rules section of this Federal Register.

Dated: October 19, 2004. 

J.I. Palmer, Jr., 

Regional Administrator, Region 4.

[FR Doc. 04–24410 Filed 11–1–04; 8:45 am] 

BILLING CODE 6560–50–P

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 27

[WT Docket No. 04–356; WT Docket No. 02–

353; FCC 04–218] 

Service Rules for Advanced Wireless 

Services in the 1915–1920 MHz, 1995–

2000 MHz, 2175–2180 MHz and 1.7 GHz 

and 2.1 GHz Bands

AGENCY: Federal Communications 

Commission.

ACTION: Proposed rule.

SUMMARY: In connection with a decision 

to provide additional twenty megahertz 

of spectrum that can be used to offer a 

variety of broadband and advanced 

wireless services (AWS), potentially 

including ‘‘third generation’’ (3G) 

wireless services, the Commission ask 

for public comment on licensing, 

technical, and operational rules to 

govern the use of the 1915–1920 MHz, 

1995–2000 MHz, and 2020–2025 MHz 

and 2175–2180 MHz bands designated 

for AWS. The Commission announced 

its desire to provide licensees of this 

spectrum with flexibility to provide any 

fixed or mobile service consistent with 

the technical parameters of allocation.

DATES: Comments are due on or before 

November 23, 2004, and reply 

comments are due on or before January 

7, 2005. Written comments on the 

Paperwork Reduction Act proposed 

information collection requirements 

must be submitted by the public, Office 

of Management and Budget (OMB), and 

other interested parties on or before 

November 23, 2004.

ADDRESSES: In addition to filing 

comments with the Secretary, a copy of 

any comments on the Paperwork 

Reduction Act information collection 

requirements contained herein should 

be submitted to Judith B. Herman, 

Federal Communications Commission, 

Room 1–C804, 445 12th Street, SW., 

Washington, DC 20554, or via the 

Internet to Judith-B.Herman@fcc.gov,

and to Kristy L. LaLonde, OMB Desk 

Officer, Room 10234 NEOB, 725 17th 

Street, NW., Washington, DC 20503 via 

the Internet to 

Kristy_L.LaLonde@omb.eop.gov, or via 

fax at 202–395–5167.

FOR FURTHER INFORMATION CONTACT:

Peter Corea at 202–418–2487. For 

additional information concerning the 

Paperwork Reduction Act information 

collection requirements contained in 

this document, contact Judith B. 

Herman at 202–418–0214, or via 

Internet at Judith-B.Herman@fcc.gov.

SUPPLEMENTARY INFORMATION: This 

document contains proposed 

information collection requirements. 

The Commission, as part of its 

continuing effort to reduce paperwork 

burdens, invites the general public and 

the Office of Management and Budget 

(OMB) to comment on the information 

collection requirements contained in 

this document, as required by the 

Paperwork Reduction Act of 1995, 

Public Law 104–13. Public and agency 

comments are due on or before 

November 23, 2004. Comments should 

address: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the Commission, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

Commission’s burden estimates; (c) 

ways to enhance the quality, utility, and 

clarity of the information collected; and 

(d) ways to minimize the burden of the 

collection of information on the 

respondents, including the use of 

automated collection techniques or 

other forms of information technology. 

In addition, pursuant to the Small