Federal Register / Vol. 67, No. 119 / Thursday, June 20, 2002 / Rules and Regulations 41821

was republished in FAA Order 7400.8J, 

dated September 20, 2001. 

This regulation only involves an 

established body of technical 

regulations for which frequent and 

routine amendments are necessary to 

keep them operationally current. It, 

therefore—(1) Is not a ‘‘significant 

regulatory action’’ under Executive 

Order 12866; (2) is not a ‘‘significant 

rule’’ under DOT Regulatory Policies 

and Procedures (44 FR 11034; February 

26, 1979); and (3) does not warrant 

preparation of a regulatory evaluation as 

the anticipated impact is so minimal. 

Since it has been determined that this 

is a routine matter that will only affect 

air traffic procedures and air navigation, 

it is certified that this rule will not have 

a significant economic impact on a 

substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

Environmental Review 

The FAA has determined that this 

action qualifies for categorical exclusion 

under the National Environmental 

Policy Act in accordance with FAA 

Order 1050.1D, Policies and Procedures 

for Considering Environmental Impacts. 

This airspace action is not expected to 

cause any potentially significant 

environmental impacts, and no 

extraordinary circumstances exist that 

warrant preparation of an 

environmental assessment.

List of Subjects in 14 CFR Part 73 

Airspace, Navigation (air).

Adoption of the Amendment 

In consideration of the foregoing, the 

Federal Aviation Administration 

amends 14 CFR part 73 as follows:

PART 73—SPECIAL USE AIRSPACE 

1. The authority citation for part 73 

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113, 

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389.

§ 73.43 [Amended] 

2. Section 73.43 is amended as 

follows:

* * * * *

R–4305 Lake Superior, MN [Amended] 

By removing the words ‘‘Using Agency. 

USAF, Detachment 1, HQ Air Combat 

Command (DOSR), Offutt AFB, NE’’ and 

inserting the words ‘‘Using Agency. USAF, 

55th Wing, Offutt AFB, NE.’’

* * * * *

Issued in Washington, DC, on June 14, 

2002. 

Reginald C. Matthews, 

Manager, Airspace and Rules Division.

[FR Doc. 02–15601 Filed 6–19–02; 8:45 am] 

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 352

[Docket No. 78N–0038]

RIN 0910–AA01

Sunscreen Drug Products for Over-theCounter Human Use; Final Monograph; 

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 established conditions 

under which over-the-counter (OTC) 

sunscreen drug products are generally 

recognized as safe and effective and not 

misbranded. This amendment updates 

the monograph to incorporate United 

States Pharmacopeia (U.S.P.) name 

changes for four active ingredients 

included in the monograph. This final 

rule is part of FDA’s ongoing review of 

OTC drug products.

DATES: This final rule is effective 

September 1, 2002. Submit written or 

electronic comments by August 19, 

2002.

ADDRESSES: Submit written or electronic 

comments to the Dockets Management 

Branch (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://

www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: John 

D. Lipnicki, 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 May 21, 

1999 (64 FR 27666), FDA issued a final 

monograph for OTC sunscreen drug 

products (21 CFR part 352). Section 

352.10 of that monograph included the 

active ingredients menthyl anthranilate, 

octyl methoxycinnamate, octyl 

salicylate, and phenylbenzimidazole 

sulfonic acid.

In 2000 (Ref. 1), the U.S.P. proposed 

(for inclusion in the Third Supplement 

to U.S.P. 24) name changes for these 

four ingredients based on names 

adopted by the United States Adopted 

Names (USAN) Council. The new names 

are: Meradimate for menthyl 

anthranilate, octinoxate for octyl 

methoxycinnamate, octisalate for octyl 

salicylate, and ensulizole for 

phenylbenzimidazole sulfonic acid. 

These name changes became official on 

March 1, 2001, and were subsequently 

included in the U.S.P. with an effective 

date of September 1, 2002 (Ref. 2).

II. Naming Process

The Federal Food, Drug, and Cosmetic 

Act (the act) requires the label of a drug 

to bear the established name of the drug 

to the exclusion of any other 

nonproprietary name (except the 

applicable systematic chemical name or 

the chemical formula) (21 U.S.C. 

352(e)(1)(A)(i)). The established name of 

the drug is defined as:

(A) the applicable official name designated 

pursuant to section 508 [of the Act], or (B) 

if there is no such name and such drug, or 

such ingredient, is an article recognized in an 

official compendium, then the official title 

thereof in such compendium, or (C) if neither 

clause (A) nor clause (B) of this subparagraph 

applies, then the common or usual name, if 

any, of such drug or of such ingredient * * 

*.

21 U.S.C. 352(e)(3)

Section 508 of the act (21 U.S.C. 358) 

authorizes FDA to designate an official 

name for any drug if FDA determines 

‘‘that such action is necessary or 

desirable in the interest of usefulness 

and simplicity’’ (21 U.S.C. 358(a)). FDA 

does not, however, routinely designate 

official names for drug products under 

section 508 of the act (§ 299.4(e) (21 

CFR 299.4(e))). In the absence of 

designation by FDA of an official name, 

interested persons may rely on the 

current compendial name as the 

established name (§ 299.4(e)).

III. The Technical Amendment

FDA has not designated official names 

for the following active ingredients: 

Menthyl anthranilate, octyl 

methoxycinnamate, octyl salicylate, and 

phenylbenzimidazole sulfonic acid. 

Thus, their established names are the 

current compendial names. The U.S.P. 

has now changed the compendial names 

to: Meradimate for menthyl 

anthranilate, octinoxate for octyl 

methoxycinnamate, octisalate for octyl 

salicylate, and ensulizole for 

phenylbenzimidazole sulfonic acid. To 

be consistent with the change in official 

compendial names, the agency is 

changing these names in § 352.10 in the 

41822 Federal Register / Vol. 67, No. 119 / Thursday, June 20, 2002 / Rules and Regulations 

ingredient listing and in § 352.20 in the 

permitted combinations listing. Because 

the active ingredients are listed in 

alphabetical order in § 352.10, the 

ingredients listed in paragraphs (f) 

through (n) are rearranged because of 

these name changes. These name 

changes will become effective on 

September 1, 2002, to coincide with the 

U.S.P. effective date.

Because section 502(e)(1) and (e)(3) of 

the act (21 U.S.C. 352(e)(1) and (e)(3)) 

require the established name of a drug 

to be used, any sunscreen drug product 

initially introduced or initially 

delivered for introduction into interstate 

commerce after September 1, 2002, will 

need to bear the new established names 

‘‘meradimate,’’ ‘‘octinoxate,’’

‘‘octisalate,’’ and ‘‘ensulizole.’’

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 agency procedure under 5 U.S.C. 

553(b)(3)(A). Alternatively, the agency’s 

implementation of this action without 

opportunity for public comment comes 

within the good cause exceptions in 5 

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

public comment is impracticable, 

unnecessary, and contrary to public 

interest. This labeling revision 

represents a minor clarifying change 

that does not change the substance of 

the labeling requirements contained in 

the final regulations. As discussed 

above, manufacturers must relabel their 

products as a result of the U.S.P. name 

change to remain in compliance with 

the act. This amendment updates the 

names of four active ingredients in the 

final monograph for OTC sunscreen 

drug products to reflect this official 

name change that has already been 

implemented by the U.S.P. In 

accordance with 21 CFR 10.40(e)(1), 

FDA is providing an opportunity for 

comment on whether the regulation 

should be modified or revoked.

IV. Analysis of Impacts

FDA has examined the impacts of the 

final rule under Executive Order 12866 

and the Regulatory Flexibility Act (5 

U.S.C. 601–612) (as amended by subtitle 

D of the Small Business Regulatory 

Fairness Act of 1996 (Public Law 104–

121)), 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 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 of 1995 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 agency concludes that this final 

rule is consistent with the principles set 

out in Executive Order 12866 and in 

these two statutes. FDA has determined 

that 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.

The Unfunded Mandates Reform Act 

of 1995 does not require FDA to prepare 

a statement of costs and benefits for this 

final rule, because the final 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 final rule is to 

update the final monograph for OTC 

sunscreen drug products to incorporate 

U.S.P. name changes for four active 

ingredients included in the monograph. 

As discussed in section II of this 

document, section 502(e)(1) and (e)(3) of 

the act require that the established name 

of a drug be used. Under § 299.4(e), 

because FDA does not routinely 

designate official names under section 

508 of the act, the established name 

under section 502(e) of the act 

ordinarily is the compendial name of 

the drug. Therefore, because FDA has 

not designated an official name under 

section 508 of the act, manufacturers 

must relabel their products as a result of 

the U.S.P. name change to remain in 

compliance with the act. Updating the 

names of the active ingredients in the 

sunscreen monograph to reflect their 

current established names will 

eliminate possible confusion by the 

public. The U.S.P. allows manufacturers 

18 months to comply with the name 

changes, and the agency’s effective date 

coincides with that of the U.S.P.

Because manufacturers must relabel 

their products as a result of the U.S.P. 

name change to remain in compliance 

with the act, this rule does not impose 

any additional costs on industry. 

Consequently, the agency certifies that 

this final rule will not have a significant 

economic impact on a substantial 

number of small entities. Therefore, no 

further analysis is required.

V. Paperwork Reduction Act of 1995

The agency concludes 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)).

VI. Environmental Impact

The agency 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, the 

agency 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. Opportunity for Comments

Interested persons may submit to the 

Dockets Management Branch (see 

ADDRESSES) written or electronic 

comments by August 19, 2002. Two 

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 

Dockets Management Branch between 9 

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

Friday.

IX. References

The following references have been 

placed on display in the Dockets 

Federal Register / Vol. 67, No. 119 / Thursday, June 20, 2002 / Rules and Regulations 41823

Management Branch (see ADDRESSES) 

and may be seen by interested persons 

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

through Friday.

1. ‘‘Pharmacopeial Forum,’’ The United 

States Pharmacopeial Convention, Inc., 

Rockville, MD, pp. 693 to 694, 717 to 719, 

and 726 to 729, May and June, 2000.

2. ‘‘Third Supplement,’’ United States 

Pharmacopeia 24, National Formulary 19, 

The United States Pharmacopeial 

Convention, Inc., Rockville, MD, pp. 3025, 

3053, 3061 to 3062, January 2, 2001.

List of Subjects in 21 CFR 352

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 352 is 

amended as follows:

PART 352—SUNSCREEN DRUG 

PRODUCTS FOR OVER-THECOUNTER HUMAN USE

1. The authority citation for 21 CFR 

part 352 continues to read as follows:

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

355, 360, 371.

2. Section 352.10 is amended by 

revising paragraphs (f) through (n) to 

read as follows:

§ 352.10 Sunscreen active ingredients.

* * * * *

(f) Ensulizole up to 4 percent.

(g) Homosalate up to 15 percent.

(h) [Reserved].

(i) Meradimate up to 5 percent.

(j) Octinoxate up to 7.5 percent.

(k) Octisalate up to 5 percent.

(l) Octocrylene up to 10 percent.

(m) Oxybenzone up to 6 percent.

(n) Padimate O up to 8 percent.

* * * * *

3. Section 352.20 is amended by 

revising paragraphs (a)(1) and (a)(2) as 

follows:

§ 352.20 Permitted combinations of active 

ingredients.

* * * * *

(a) Combinations of sunscreen active 

ingredients. (1) Two or more sunscreen 

active ingredients identified in §

352.10(a), (c), (e), (f), (g), and (i) through 

(r) may be combined with each other in 

a single product when used in the 

concentrations established for each 

ingredient in § 352.10. The 

concentration of each active ingredient 

must be sufficient to contribute a 

minimum SPF of not less than 2 to the 

finished product. The finished product 

must have a minimum SPF of not less 

than the number of sunscreen active 

ingredients used in the combination 

multiplied by 2.

(2) Two or more sunscreen active 

ingredients identified in § 352.10(b), (c), 

(e), (g), (j) through (m), (o), and (q) may 

be combined with each other in a single 

product when used in the 

concentrations established for each 

ingredient in § 352.10. The 

concentration of each active ingredient 

must be sufficient to contribute a 

minimum SPF of not less than 2 to the 

finished product. The finished product 

must have a minimum SPF of not less 

than the number of sunscreen active 

ingredients used in the combination 

multiplied by 2.

* * * * *

Dated: June 11, 2002.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–15632 Filed 6–19–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 522, and 529

Certain Other Dosage Form New 

Animal Drugs; Progesterone 

Intravaginal Inserts

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 new animal drug 

application (NADA) filed by DEC 

International, Inc. The NADA provides 

for use of progesterone intravaginal 

inserts for manipulation of estrus in 

cattle.

DATES: This rule is effective June 20, 

2002.

FOR FURTHER INFORMATION CONTACT:

Harlan J. Howard, Center for Veterinary 

Medicine (HFV–126), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–0231, email: hhoward@cvm.fda.gov.

SUPPLEMENTARY INFORMATION: DEC 

International, Inc., 1919 South 

Stoughton Rd., P.O. Box 8050, Madison 

WI 53708–8050, filed NADA 141–200 

that provides for use of EAZI–BREED 

CIDR Progesterone Intravaginal Inserts 

for synchronization of estrus in suckled 

beef cows and replacement beef and 

dairy heifers, for advancement of first 

postpartum estrus in suckled beef cows, 

and for advancement of first pubertal 

estrus in replacement beef heifers. The 

NADA is approved as of May 2, 2002, 

and the regulations in 21 CFR part 529 

are amended by adding § 529.1940 to 

reflect the approval. The regulation in 

21 CFR 522.690 is being amended to 

add a cross-reference for the concurrent 

use of dinoprost solution by 

intramuscular injection and is being 

revised to reflect a current format. The 

basis of approval is discussed in the 

freedom of information summary.

In addition, DEC International, Inc., 

has not been previously listed in the 

animal drug regulations as a sponsor of 

an approved application. At this time, 

21 CFR 510.600(c) is being amended to 

add entries for the firm.

In accordance with the freedom of 

information provisions of 21 CFR part 

20 and 514.11(e)(2)(ii), a summary of 

safety and effectiveness data and 

information submitted to support 

approval of this application may be seen 

in the Dockets Management Branch 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852, between 9 

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

Friday.

Under section 512(c)(2)(F)(ii) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 360b(c)(2)(F)(ii)), this 

approval qualifies for 3 years of 

marketing exclusivity beginning May 2, 

2002.

The agency has carefully considered 

the potential environmental effects of 

this action. FDA has concluded that the 

action will not have a significant impact 

on the human environment, and that an 

environmental impact statement is not 

required. The agency’s finding of no 

significant impact and the evidence 

supporting that finding, contained in an 

environmental assessment, may be seen 

in the Dockets Management Branch (see 

ADDRESSES) between 9 a.m. and 4 p.m., 

Monday through Friday.

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808.

List of Subjects

21 CFR Part 510

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements.

21 CFR Parts 522 and 529

Animal drugs.

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR parts 510, 522, and 529 are 

amended as follows: