6014 Federal Register / Vol. 73, No. 22 / Friday, February 1, 2008 / Rules and Regulations 

Commission’s EDGAR system or who 

submits funds to the U.S. Treasury 

designated depository in anticipation of 

paying a filing fee. Account statements 

are regularly prepared and provided to 

account holders. Account holders must 

maintain a current account address with 

the Commission to ensure timely access 

to these statements. 

Note to paragraph (d). The deposit of 

money into a filing fee account does not 

constitute payment of a filing fee. Payment of 

the filing fee occurs at the time the filing is 

made, commensurate with the drawing down 

of the balance of the fee account. 

(e) Return of funds from inactive 

accounts. Funds held in any filing fee 

account in which there has not been a 

deposit, withdrawal or other adjustment 

for more than 180 calendar days will be 

returned to the account holder, and 

account statements will not be sent 

again until a deposit, withdrawal or 

other adjustment is made with respect 

to the account. Filers must maintain a 

current account address to assure the 

timely return of funds. It may not be 

possible to return funds from inactive 

accounts if the Commission is unable to 

identify a current account address of an 

account holder after making reasonable 

efforts to do so. 

Note to paragraph (e). A company must 

update its account and other addresses using 

the EDGAR Web site. This method ensures 

data integrity and the timeliest update. 

Simply changing an address in the text of the 

cover page of a filing made on the EDGAR 

system will not be sufficient to update the 

Commission’s account address records. 

PART 230—GENERAL RULES AND 

REGULATIONS, SECURITIES ACT OF 

1933 

■ 3. The authority citation for part 230 

continues to read in part as follows: 

Authority: 15 U.S.C. 77b, 77c, 77d, 77f, 

77g, 77h, 77j, 77r, 77s, 77z–3, 77sss, 78c, 78d, 

78j, 78l, 78m, 78n, 78o, 78t, 78w, 78ll(d), 

78mm, 80a–8, 80a–24, 80a–28, 80a–29, 80a–

30, and 80a–37, unless otherwise noted. 

* * * * * 

■ 4. Section 230.111 is revised to read 

as follows: 

§ 230.111 Payment of fees. 

All payments of fees for registration 

statements under the Act shall be made 

by wire transfer, or by certified check, 

bank cashier’s check, United States 

postal money order, or bank money 

order payable to the Securities and 

Exchange Commission, omitting the 

name or title of any official of the 

Commission. There will be no refunds. 

Payment of fees required by this section 

shall be made in accordance with the 

directions set forth in § 202.3a of this 

chapter. 

PART 240—GENERAL RULES AND 

REGULATIONS, SECURITIES 

EXCHANGE ACT OF 1934 

■ 5. The authority citation for part 240 

continues to read in part as follows: 

Authority: 15 U.S.C. 77c, 77d, 77g, 77j, 

77s, 77z–2, 77z–3, 77eee, 77ggg, 77nnn, 

77sss, 77ttt, 78c, 78d, 78e, 78f, 78g, 78i, 78j, 

78j–1, 78k, 78k–1, 78l, 78m, 78n, 78o, 78p, 

78q, 78s, 78u–5, 78w, 78x, 78ll, 78mm, 80a–

20, 80a–23, 80a–29, 80a–37, 80b–3, 80b–4, 

80b–11, and 7201 et seq.; and 18 U.S.C. 1350, 

unless otherwise noted. 

* * * * * 

■ 6. Section. 240.0–9 is revised to read 

as follows: 

§ 240.0–9 Payment of fees. 

All payment of fees shall be made by 

wire transfer, or by certified check, bank 

cashier’s check, United States postal 

money order, or bank money order 

payable to the Securities and Exchange 

Commission, omitting the name or title 

of any official of the Commission. 

Payment of filing fees required by this 

section shall be made in accordance 

with the directions set forth in § 202.3a 

of this chapter. 

PART 260—GENERAL RULES AND 

REGULATIONS, TRUST INDENTURE 

ACT OF 1939 

■ 7. The authority citation for part 260 

continues to read as follows: 

Authority: 15 U.S.C. 77eee, 77ggg, 77nnn, 

77sss, 78ll(d), 80b–3, 80b–4, and 80b–11. 

§ 260.7a–10 [Removed] 

■ 8. Section 260.7a–10 is removed. 

PART 270—RULES AND 

REGULATIONS, INVESTMENT 

COMPANY ACT OF 1940 

■ 9. The authority citation for part 270 

continues to read in part as follows: 

Authority: 15 U.S.C. 80a–1 et seq., 80a–

34(d), 80a–37, and 80a–39, unless otherwise 

noted. 

* * * * * 

■ 10. Section 270.0–8 is revised to read 

as follows: 

§ 270.0–8 Payment of fees. 

All payment of fees shall be made by 

wire transfer, or by certified check, bank 

cashier’s check, United States postal 

money order, or bank money order 

payable to the Securities and Exchange 

Commission, omitting the name or title 

of any official of the Commission. 

Payment of fees required by this section 

shall be made in accordance with the 

directions set forth in § 202.3a of this 

chapter. 

By the Commission. 

Dated: January 29, 2008. 

Nancy M. Morris, 

Secretary. 

[FR Doc. E8–1839 Filed 1–31–08; 8:45 am] 

BILLING CODE 8011–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 347 

[Docket Nos. 1978N–0021 and 1978N–

0021P] (formerly Docket Nos. 78N–0021 and 

78N–0021P) 

RIN 0910–AF42 

Skin Protectant Drug Products for 

Over-the-Counter Human Use; 

Reduced Labeling; Technical 

Amendment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

regulation that establishes conditions 

under which over-the-counter (OTC) 

skin protectant drug products are 

generally recognized as safe and 

effective (GRASE) and not misbranded. 

This amendment revises labeling 

requirements for OTC skin protectant 

drug products formulated and marketed 

as lip protectants. 

DATES: This rule is effective March 3, 

2008. 

FOR FURTHER INFORMATION CONTACT: 

Michael L. Koenig, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Silver Spring, 

MD 20993, 301–796–2090. 

SUPPLEMENTARY INFORMATION: 

I. Why Are We Publishing This 

Document? 

This document addresses submissions 

that FDA received in response to a June 

4, 2003, final rule for OTC skin 

protectant drug products (68 FR 33362). 

The final rule establishes reduced 

labeling requirements for the following 

products (68 FR 33362 at 33374): 

• products formulated and labeled as 

lip protectants that meet the criteria 

established in § 201.66(d)(10) (21 CFR 

201.66(d)(10)) (§ 347.50(e)); 

• products containing only cocoa 

butter, petrolatum, or white petrolatum 


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identified in § 347.10(d), (m), and (r), 

used singly or in combination with each 

other, and marketed other than as a lip 

protectant (§ 347.50(f)); 

• sunscreen drug products labeled for 

use only on specific small areas of the 

face (e.g., lips, nose, ears, and around 

the eyes) and that meet the criteria 

established in § 201.66(d)(10) 

(§ 352.52(f)); and 

• products containing combinations 

of skin protectant and sunscreen active 

ingredients (§ 352.60(b)(2), (c), and (d)). 

Because we had not previously 

proposed this reduced labeling, we 

requested comments specifically on 

these new labeling requirements. This 

document addresses the five issues 

presented in the three sets of comments 

that we received after the final rule. All 

of the comments request changes to 

existing regulatory requirements. As 

explained in section II of this document, 

we agree to make the changes requested 

in two of the comments and are, 

therefore, amending the final rule to: 

• add an alternative statement of 

identity for skin protectant products 

formulated and marketed as lip 

protectants and 

• allow omission of a warning for lip 

protectant products that meet the 

criteria established in § 201.66(d)(10). 

As also explained in section II of this 

document, we do not agree to make the 

other three changes requested in the 

submissions. 

II. What Are Our Conclusions on the 

Submissions? 

(Comment 1) A drug manufacturer 

requested that we include the term ‘‘lip 

protectant’’ as an alternative statement 

of identity for skin protectants marketed 

as lip protectants (Ref. 1). The 

manufacturer notes that we have 

distinctly identified products 

formulated and marketed as lip 

protectants in other areas of the skin 

protectant final rule, including §§ 347.3 

and 347.50(b)(2)(ii), (e), and (f). The 

manufacturer further points out that we 

have permitted a product used to treat 

poison ivy, oak, and sumac to be 

distinctly identified as a ‘‘poison ivy, 

oak, sumac protectant’’ in § 347.50(a)(3). 

We agree with the manufacturer and 

are including the term ‘‘lip protectant’’

as an alternative statement of identity 

for skin protectant drug products 

formulated and marketed as lip 

protectants. We agree that the term ‘‘lip 

protectant’’ accurately describes this 

category of products and is readily 

understood by consumers. Accordingly, 

we are adding the following new 

paragraph in § 347.50(a): For any 

product formulated as a lip protectant. 

‘‘Skin protectant,’’ ‘‘lip protectant,’’ or 

‘‘lip balm’’ (optional, may add dosage 

form, e.g., ‘‘cream,’’ ‘‘gel,’’ ‘‘lotion,’’ or 

‘‘ointment’’). 

(Comment 2) A drug manufacturer 

requested that we allow reduced 

labeling for all lip protectant products, 

whether or not they meet the criteria 

established in § 201.66(d)(10) (i.e., 

whether or not they are sold in small 

packages) (Ref. 1). The manufacturer 

states that the skin protectant final rule 

(68 FR 33362 at 33380 to 33381) amends 

the final rule for OTC sunscreen drug 

products to allow reduced labeling 

‘‘without the need to meet the criteria 

established in § 201.66(d)(10)’’ for the 

following products: 

• Sunscreen products that are 

marketed as lip protectants or lipsticks 

(§ 352.52(c)(2) and (d)(4)) and 

• Combination sunscreen-skin 

protectant drug products marketed as 

lip protectants or lipsticks (§ 352.60(c) 

and (d)). 

Because the skin protectant monograph 

(§ 347.50(e)) allows reduced labeling 

only for lip protectants that meet the 

criteria in § 201.66(d)(10), the 

manufacturer argues that the skin 

protectant and sunscreen monographs 

are inconsistent. 

We have determined that the reduced 

labeling requirements established under 

§ 347.50(e) for OTC lip protectant 

products are appropriate only if the 

criteria of § 201.66(d)(10) are met. If the 

criteria of § 201.66(d)(10) are not met, at 

least one of the factors upon which we 

relied to conclude that minimal 

information is needed for safe and 

effective use of lip protectants would 

not apply, namely, the product would 

not necessarily be sold in small 

packages (see 68 FR 33362 at 33371). 

Further, if the § 201.66(d)(10) criteria 

are not met, space constraints would not 

exist to support reduced labeling. We 

believe the current labeling 

requirements for lip protectant products 

that do not satisfy the § 201.66(d)(10) 

criteria benefit consumers and should 

continue to apply. 

Therefore, we are not revising the 

criteria for reduced labeling in the skin 

protectant monograph. We will address, 

in a separate rulemaking for the 

sunscreen monograph, whether 

sunscreen lip protectant products (i.e., 

sunscreen products marketed as lip 

protectants or combination sunscreenskin protectant drug products marketed 

as lip protectants or lipsticks) should 

also be required to satisfy the conditions 

of § 201.66(d)(10) in order to qualify for 

reduced labeling requirements. We 

intend to publish a sunscreen 

rulemaking in a future issue of the 

Federal Register. The rulemaking will 

address various labeling and testing 

requirements for both ultraviolet A 

(UVA) and ultraviolet B (UVB) rays, 

including reduced labeling 

requirements for sunscreen lip 

protectant products. 

(Comment 3) A drug manufacturer 

argued that the warning statement 

exemption allowed for sunscreens 

combined with skin protectants 

(§ 352.60(c)) should be extended to all 

lip protectant products (Ref. 1). Section 

352.60(c) of the sunscreen monograph 

permits sunscreen-skin protectant 

combinations to omit the warning in 

§ 347.50(c)(3): ‘‘Stop use and ask a 

doctor if [bullet] condition worsens 

[bullet] symptoms last more than 7 days 

or clear up and occur again within a few 

days.’’ The manufacturer points out that 

the skin protectant monograph does not 

allow this warning to be omitted for 

skin protectants formulated and labeled 

as lip protectants. Section 

347.50(e)(1)(iii) of the skin protectant 

monograph allows the warning to be 

shortened (i.e., ‘‘Stop use and ask a 

doctor if condition lasts more than 7 

days’’) but not omitted. The 

manufacturer argues that the 

requirement for this warning makes the 

skin protectant and sunscreen 

monographs inconsistent. 

We agree with the manufacturer and 

are changing the skin protectant 

monograph to allow the warning to be 

omitted for lip protectant products that 

meet the requirements in 

§ 201.66(d)(10). In the preamble to the 

skin protectant final rule, we concluded 

that minimal information is needed for 

safe and effective use of lip protectant 

products because of specific 

characteristics of these products (68 FR 

33362 at 33371), including that they: 

• are typically packaged in small 

amounts, 

• are applied to limited areas of the 

body, 

• have high therapeutic index, 

• are extremely low risk in consumer 

use situations, 

• provide a favorable public health 

benefit, 

• require no specified dosage 

limitation, and 

• require few specific warnings and 

no general warnings. 

Because minimal information is needed 

for their safe and effective use, we agree 

that lip protectant products meeting the 

criteria in § 201.66(d)(10) can be 

exempted from the 7-day warning 

requirement otherwise applicable to 

skin protectants under § 347.50(c)(3). 

We believe consumers can safely and 

effectively use these products without 

this warning. Accordingly, we are 

revising § 347.50(e)(1)(iii) in the skin 

protectant monograph to read: ‘‘The 


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‘external use only’ warning in 

§ 347.50(c)(1) and in § 201.66(c)(5)(i) of 

this chapter may be omitted. The 

warnings in § 347.50(c)(2), (c)(3), and 

(c)(4) are not required.’’ This revision 

will make the skin protectant and 

sunscreen monographs consistent in 

this regard, as requested by the 

manufacturer. 

(Comment 4) A law firm requested 

that we allow additional reduced 

labeling for lip protectants and all other 

skin protectant drug products by 

eliminating the requirement to list the 

established name of an active ingredient 

both on the principal display panel 

(PDP) and in the Drug Facts box (Ref. 2). 

The law firm argues that the PDP for 

skin protectants and, in fact, most OTC 

drug products should only include the 

general pharmacological category as the 

statement of identity. 

The issue raised by the law firm is 

outside the scope of the reduced 

labeling issues for which we sought 

comments in the skin protectant final 

rule. We do not believe it appropriate to 

address this issue in this document 

because the issue impacts the labeling 

for all OTC drug products. The law firm, 

or any other party interested in 

amending the OTC labeling regulations, 

can submit a citizen petition in 

accordance with 21 CFR 10.30. 

(Comment 5) A drug manufacturers’

association requested that we consider a 

greater degree of flexibility in the 

reduced labeling allowed for skin 

protectant (lip protectant) and skin 

protectant-sunscreen combination 

products (Ref. 3). Specifically, the 

association asks that we permit 

manufacturers to list inactive 

ingredients somewhere other than on 

the container label for ‘‘products such as 

lip balms and lip balms with 

sunscreen,’’ which are sold in very 

small containers similar to lipsticks 

containing sunscreens. The association 

notes that we permit this labeling 

exception for some cosmetic products. 

We are denying the request to list 

inactive ingredients somewhere other 

than on the container label for skin 

protectant and skin protectantsunscreen combination drug products. 

We do allow listing of inactive 

ingredients for some cosmetic products 

in labeling accompanying the product 

rather than on the container label (21 

CFR 701.3(i)). However, we do not allow 

inactive ingredients to be listed 

somewhere other than on the container 

label if the cosmetic product is also a 

drug product (e.g., a lipstick containing 

sunscreen). 

Section 502(e)(1)(A)(iii) of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 352(e)(1)(A)(iii)) requires that 

the inactive ingredients of a drug be 

listed on the outside of the retail 

package and, if determined to be 

appropriate by FDA, on the immediate 

container. Under § 201.66, the 

regulation implementing section 

502(e)(1)(A)(iii) for OTC drugs, inactive 

ingredients must be listed on the 

outside container of a retail package or 

on the immediate container of the 

product if there is no outside container 

or wrapper. The association asserts that 

section 502(e)(1)(B) of the act (21 U.S.C. 

352(e)(1)(B)) gives us the ‘‘authority to 

grant relief from the inactive ingredient 

listing requirements in appropriate 

circumstances.’’ However, section 

502(e)(1)(B) addresses only prescription 

drug labeling. We do not find a basis for 

allowing an option to list the inactive 

ingredients of an OTC drug product in 

a different location, such as in other 

labeling accompanying the product. 

III. Analysis of Economic Impacts 

We have 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 (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 final rule is not a 

significant regulatory action under 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. This rule provides an 

additional statement of identity for OTC 

skin protectant drug products. The 

revision provides manufacturers of OTC 

lip protectant drug products the option 

to label their products as a ‘‘lip 

protectant’’ or ‘‘lip balm’’ in addition to 

‘‘skin protectant,’’ as required by the 

monograph. The rule also allows 

manufacturers to omit a warning if the 

packaging meets the requirements of 

§ 201.66(d)(10). Thus, this rule does not 

impose any new requirements. Rather, 

manufacturers may make these changes 

if they wish to do so. If manufacturers 

choose to make the changes, they may 

do so when ordering new labeling in the 

normal course of business. Therefore, 

we do not believe that this final rule 

will 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 $127 

million, using the most current (2006) 

Implicit Price Deflator for the Gross 

Domestic Product. We do not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

IV. Paperwork Reduction Act of 1995 

We conclude that the 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 labeling statements 

are 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)). 

V. Federalism 

We have analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. We have 

determined that this final rule has a 

preemptive effect on State law. 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.’’

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

is an express preemption provision. 

Section 751(a) of the act (21 U.S.C. 

379r(a)) provides that ‘‘* * * no State 

or political subdivision of a State may 

establish or continue in effect any 

requirement—(1) that relates to the 

regulation of a drug that is not subject 

to the requirements of section 503(b)(1) 

or 503(f)(1)(A); and (2) that is different 

from or in addition to, or that is 

otherwise not identical with, a 

requirement under this Act, the Poison 

Prevention Packaging Act of 1970 (15 

U.S.C. 1471 et seq.), or the Fair 

Packaging and Labeling Act (15 U.S.C. 

1451 et seq.).’’ Currently, this provision 

operates to preempt States from 


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Federal Register / Vol. 73, No. 22 / Friday, February 1, 2008 / Rules and Regulations 6017 

imposing requirements related to the 

regulation of nonprescription drug 

products. Section 751(b) through (e) of 

the act outlines the scope of the express 

preemption provision, the exemption 

procedures, and the exceptions to the 

provision. 

This final rule provides an additional 

statement of identity for skin protectants 

formulated and marketed as lip 

protectants and allows omission of a 

warning for certain lip protectant 

products. Any final rule has a 

preemptive effect in that it precludes 

States from issuing requirements related 

to the labeling of OTC skin protectant 

drug products that are different from or 

in addition to, or not otherwise identical 

with a requirement in the final rule. 

This preemptive effect is consistent 

with what Congress set forth in section 

751 of the act. Section 751(a) of the act 

displaces both State legislative 

requirements and State common law 

duties. We also note that even where the 

express preemption provision is not 

applicable, implied preemption may 

arise (see Geier v. American Honda Co., 

529 US 861 (2000)). 

We believe that the preemptive effect 

of the final rule is consistent with 

Executive Order 13132. Section 4(e) of 

the Executive order provides that ‘‘when 

an agency proposes to act through 

adjudication or rulemaking to preempt 

State law, the agency shall provide all 

affected State and local officials notice 

and an opportunity for appropriate 

participation in the proceedings.’’

We provided the States with an 

opportunity for appropriate 

participation in this rulemaking when 

we sought input from all stakeholders 

on the reduced labeling requirements 

that this rulemaking addresses, through 

publication of the request for comments 

in the Federal Register in the preamble 

to the final rule on June 4, 2003 (68 FR 

33362). We received no comments from 

any States in response to the request. 

In addition, on December 10, 2007, 

FDA’s Division of Federal and State 

Relations provided notice via e-mail 

transmission to elected officials of State 

governments and their representatives 

of national organization. The notice 

provided the States with further 

opportunity to comment. It advised the 

States of the publication of the request 

for comments and encouraged State and 

local governments to review the request 

and to provide any comments to the 

dockets for this rulemaking (Docket Nos. 

1978N–0021 and 1978N–0021P) by a 

date 30 days after the date of the notice 

(i.e., by January 10, 2008), or to contact 

certain named individuals. FDA 

received no comments in response to 

this notice. The notice has been filed in 

the previously mentioned dockets. 

In conclusion, we believe that we 

have complied with all of the applicable 

requirements under the Executive order 

and have determined that the 

preemptive effects of this rule are 

consistent with Executive Order 13132. 

VI. 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. 

VII. References 

The following references are on 

display in the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852 under 

Docket No. 1978N–0021 and may be 

seen by interested persons between 9 

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

Friday. 

1. Comment No. C67. 

2. Comment No. C68. 

3. Comment No. C69. 

List of Subjects in 21 CFR Part 347 

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, 21 CFR part 347 is 

amended as follows: 

PART 347—SKIN PROTECTANT DRUG 

PRODUCTS FOR OVER-THECOUNTER HUMAN USE 

■ 1. The authority citation for 21 CFR 

part 347 continues to read as follows: 

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

355, 360, 371. 

■ 2. Section 347.50 is amended by 

revising paragraphs (a) and (e)(1)(iii) to 

read as follows: 

§ 347.50 Labeling of skin protectant drug 

products. 

* * * * * 

(a) Statement of identity. The labeling 

of the product contains the established 

name of the drug, if any, and identifies 

the product with one or more of the 

following: 

(1) For any product. ‘‘Skin protectant’’

(optional, may add dosage form, e.g., 

‘‘cream,’’ ‘‘gel,’’ ‘‘lotion,’’ or 

‘‘ointment’’). 

(2) For any product formulated as a 

lip protectant. ‘‘Skin protectant,’’ ‘‘lip 

protectant,’’ or ‘‘lip balm’’ (optional, 

may add dosage form, e.g., ‘‘cream,’’

‘‘gel,’’ ‘‘lotion,’’ or ‘‘ointment’’). 

(3) For products containing any 

ingredient in § 347.10(b), (c), (j), (s), (t), 

and (u). ‘‘Poison ivy, oak, sumac 

drying’’ (optional, may add dosage form, 

e.g., ‘‘cream,’’ ‘‘gel,’’ ‘‘lotion,’’ or 

‘‘ointment’’). 

(4) For products containing any 

ingredient in § 347.10(b), (c), (f), (j), (o), 

(s), (t), and (u). ‘‘Poison ivy, oak, sumac 

protectant.’’

* * * * * 

(e) Products formulated and labeled 

as a lip protectant and that meet the 

criteria established in § 201.66(d)(10) of 

this chapter. * * * 

(1) * * * 

(iii) The ‘‘external use only’’ warning 

in § 347.50(c)(1) and in § 201.66(c)(5)(i) 

of this chapter may be omitted. The 

warnings in § 347.50(c)(2), (c)(3), and 

(c)(4) are not required. 

* * * * * 

Dated: January 28, 2008. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E8–1818 Filed 1–31–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 522 

Implantation or Injectable Dosage 

Form New Animal Drugs; 

Tulathromycin 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect 

approval of a supplemental new animal 

drug application (NADA) filed by Pfizer, 

Inc. The supplemental NADA provides 

for veterinarian prescription use of 

tulathromycin injectable solution for the 

treatment of infectious bovine 

keratoconjunctivitis and the addition of 

a pathogen to the indication for use for 

treatment of swine respiratory disease. 

DATES: This rule is effective February 1, 

2008. 

FOR FURTHER INFORMATION CONTACT: Joan 

C. Gotthardt, Center for Veterinary 

Medicine (HFV–130), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8342, email: joan.gotthardt@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pfizer, 

Inc., 235 East 42d St., New York, NY 

10017, filed a supplement to NADA 

141–244 for DRAXXIN (tulathromycin) 


pwalker on PROD1PC71 with PROPOSALS