Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Rules and Regulations 9765 

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

355, 360, 371. 

■ 4. Section 347.20 is amended by 

redesignating paragraphs (b), (c), and (d) 

as paragraphs (c), (d), and (e), 

respectively, and by adding new 

paragraph (b) to read as follows: 

§ 347.20 Permitted combinations of active 

ingredients. 

* * * * * 

(b) Combination of ingredients to 

prepare an aluminum acetate solution. 

Aluminum sulfate tetradecahydrate may 

be combined with calcium acetate 

monohydrate in powder or tablet form 

to provide a 0.13 to 0.5 percent 

aluminum acetate solution when the 

powder or tablet is dissolved in the 

volume of water specified in 

‘‘Directions.’’ 

* * * * * 

■ 5. Section 347.52 is amended by 

revising paragraph (a) and (b)(1) 

paragraph heading, and by revising 

paragraphs (c) and (d)(1), and by adding 

new paragraph (d)(4) to read as follows: 

§ 347.52 Labeling of astringent drug 

products. 

(a) Statement of identity. The labeling 

of the product contains the established 

name of the drug, if any, and identifies 

the product as an ‘‘astringent.’’ For 

products containing the combination of 

aluminum sulfate tetradecahydrate and 

calcium acetate monohydrate identified 

in § 347.20(b), under the ‘‘Purpose’’ 

heading identified in § 201.66(c)(3) of 

this chapter, the labeling of each active 

ingredient in the product states 

‘‘Astringent*’’, which is followed by the 

statements ‘‘* When combined together 

in water, these ingredients form the 

active ingredient aluminum acetate. See 

[the following in bold italic type] 

Directions.’’ 

(b) Indications. * * * 

(1) For products containing aluminum 

acetate identified in § 347.12(a) or the 

combination of aluminum sulfate 

tetradecahydrate and calcium acetate 

monohydrate identified in § 347.20(b). 

* * * 

* * * * * 

(c) Warnings. The labeling of the 

product contains the following warnings 

under the heading ‘‘Warnings’’: 

(1) For all products—(i) The labeling 

states ‘‘For external use only’’. 

(ii) The labeling states ‘‘When using 

this product [bullet] avoid contact with 

eyes. If contact occurs, rinse thoroughly 

with water.’’ 

(2) For products containing aluminum 

acetate identified in § 347.12(a), witch 

hazel identified in § 347.12(c), or the 

combination of aluminum sulfate 

tetradecahydrate and calcium acetate 

monohydrate identified in § 347.20(b). 

The labeling states ‘‘Stop use and ask a 

doctor if [bullet] condition worsens or 

symptoms last more than 7 days’’. 

(3) For products containing aluminum 

acetate identified in § 347.12(a) or the 

combination of aluminum sulfate 

tetradecahydrate and calcium acetate 

monohydrate identified in § 347.20(b) 

when labeled for use as a compress or 

wet dressing. The labeling states ‘‘When 

using this product [bullet] do not cover 

compress or wet dressing with plastic to 

prevent evaporation’’. 

(4) For products containing aluminum 

acetate identified in § 347.12(a) or the 

combination of aluminum sulfate 

tetradecahydrate and calcium acetate 

monohydrate identified in § 347.20(b) 

when labeled for use as a soak, 

compress, or wet dressing. The labeling 

states ‘‘When using this product [bullet] 

in some skin conditions, soaking too 

long may overdry’’. 

(d) Directions. * * * 

(1) For products containing aluminum 

acetate identified in § 347.12(a) or the 

combination of aluminum sulfate 

tetradecahydrate and calcium acetate 

monohydrate identified in § 347.20(b)— 

(i) For products used as a soak. ‘‘For use 

as a soak: [preceding words in bold 

type] [bullet] soak affected area for 15 to 

30 minutes as needed, or as directed by 

a doctor [bullet] repeat 3 times a day or 

as directed by a doctor [bullet] discard 

solution after each use’’ . 

(ii) For products used as a compress 

or wet dressing. ‘‘For use as a compress 

or wet dressing: [preceding words in 

bold type] [bullet] soak a clean, soft 

cloth in the solution [bullet] apply cloth 

loosely to affected area for 15 to 30 

minutes [bullet] repeat as needed or as 

directed by a doctor [bullet] discard 

solution after each use’’. 

* * * * * 

(4) For products containing the 

combination of aluminum sulfate 

tetradecahydrate and calcium acetate 

monohydrate identified in § 347.20(b)— 

(i) For powder dosage form. The labeling 

states ‘‘[bullet] dissolve 1 to 3 packets in 

[insert volume] of cool or warm water 

[bullet] stir until fully dissolved; do not 

strain or filter. The resulting mixture 

contains [insert percent] (1 packet), 

[insert percent] (2 packets), or [insert 

percent] (3 packets) aluminum acetate 

and is ready for use.’’ These statements 

shall be the first statements under the 

heading ‘‘Directions’’. 

(ii) For tablet dosage form. The 

labeling states ‘‘[bullet] dissolve 1 to 3 

tablets in [insert volume] of cool or 

warm water [bullet] stir until fully 

dissolved; do not strain or filter. The 

resulting mixture contains [insert 

percent] (1 tablet), [insert percent] (2 

tablets), or [insert percent] (3 tablets) 

aluminum acetate and is ready for use.’’ 

These statements shall be the first 

statements under the heading 

‘‘Directions’’. 

* * * * * 

Dated: February 23, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–4746 Filed 3–5–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 314 

[Docket No. FDA–2009–N–0099] 

New Drug Applications and 

Abbreviated New Drug Applications; 

Technical Amendment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

new drug application (NDA) and 

abbreviated new drug application 

(ANDA) regulations to update agency 

contacts for patent information and 

patent notifications and to correct an 

inaccurate cross-reference. This action 

is being taken to ensure accuracy and 

clarity in the agency’s regulations. 

DATES: This rule is effective March 6, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

Olivia A. Pritzlaff, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, Bldg. 51, rm. 

6308, 10903 New Hampshire Ave., 

Silver Spring, MD 20993–0002, 301– 

796–3506. 

SUPPLEMENTARY INFORMATION: FDA is 

amending its NDA and ANDA 

regulations in part 314 (21 CFR part 

314) to update agency contacts for 

information and notifications pertaining 

to patents and to correct an inaccurate 

reference. To accommodate the ongoing 

relocation of FDA offices, users are 

directed to FDA’s Web site to obtain the 

current address of the Office of Generic 

Drugs. 

In §§ 314.52(a)(2) and 314.95(a)(2), 

FDA is updating the agency contact for 

obtaining the name and address of the 

NDA holder or designee for purposes of 

providing notice of a patent certification 

submitted under section 505(b)(2)(A)(iv) 

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9766 Federal Register / Vol. 74, No. 43 / Friday, March 6, 2009 / Rules and Regulations 

or 505(j)(2)(A)(vii)(IV) of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 355(b)(2)(A)(iv) or 

355(j)(2)(A)(vii)(IV)). The Division of 

Drug Information Resources no longer 

exists. The agency contact for this 

information is now the Orange Book 

Staff, Office of Generic Drugs. 

In § 314.53(f), FDA is updating the 

agency unit to which notifications of 

requests for correction of patent 

information should be directed. The 

Drug Information Services Branch no 

longer exists. These notifications should 

now be sent to the Office of Generic 

Drugs Document Room, attention the 

Orange Book Staff. 

In § 314.107(e), FDA is updating the 

listing of agency units to which a 

505(b)(2) applicant must send 

notification of entry of an order or 

judgment in a court action. Instead of 

the appropriate division in the Office of 

Drug Evaluation I and Office of Drug 

Evaluation II, these notifications should 

now be sent to the appropriate division 

in the Office of New Drugs. 

In § 314.107(f)(2)(iv), FDA is updating 

the agency recipient of a 505(b)(2) 

applicant’s required notification that a 

legal action has been filed within 45 

days of receipt of a notice of paragraph 

IV certification (submitted under section 

505(b)(2)(A)(iv) of the act) from the 

appropriate division in the Center for 

Drug Evaluation and Research to the 

appropriate division in the Office of 

New Drugs. 

In § 314.125(b)(16), FDA is correcting 

a cross-reference to the agency’s 

regulations on institutional review 

boards (21 CFR part 56) by replacing 

‘‘part 58’’ with ‘‘part 56.’’ 

Publication of this document 

constitutes final action under the 

Administrative Procedure Act (5 U.S.C. 

553). FDA has determined that notice 

and public comment are unnecessary 

because the amendments to the 

regulations provide only technical 

changes to correct an inaccurate citation 

and to update agency contacts, and are 

nonsubstantive. 

List of Subjects in 21 CFR Part 314 

Administrative practice and 

procedure, Confidential business 

information, Drugs, Reporting and 

recordkeeping requirements. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 314 is 

amended as follows: 

PART 314—APPLICATIONS FOR FDA 

APPROVAL TO MARKET A NEW DRUG 

■ 1. The authority citation for 21 CFR 

part 314 continues to read as follows: 

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

353, 355, 356, 356a, 356b, 356c, 371, 374, 

379e. 

§ 314.52 [Amended] 

■ 2. Section 314.52 is amended in 

paragraph (a)(2) by removing ‘‘Division 

of Drug Information Resources (HFD– 

80), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857’’ and by adding in 

its place ‘‘Orange Book Staff, Office of 

Generic Drugs, at the address identified 

on FDA’s Web site (http://www.fda.gov/ 

cder/ogd)’’. 

§ 314.53 [Amended] 

■ 3. Section 314.53 is amended in 

paragraph (f) by removing ‘‘Drug 

Information Services Branch (HFD–84), 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857’’ and by adding in 

its place ‘‘Office of Generic Drugs, OGD 

Document Room, Attention: Orange 

Book Staff, at the address identified on 

FDA’s Web site (http://www.fda.gov/ 

cder/ogd)’’. 

§ 314.95 [Amended] 

■ 4. Section 314.95 is amended in 

paragraph (a)(2) by removing ‘‘Division 

of Drug Information Resources (HFD– 

80), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857’’ and by adding in 

its place ‘‘Orange Book Staff, Office of 

Generic Drugs, at the address identified 

on FDA’s Web site (http://www.fda.gov/ 

cder/ogd)’’. 

§ 314.107 [Amended] 

■ 5. Section 314.107 is amended in 

paragraph (e) by removing ‘‘Office of 

Drug Evaluation I (HFD–100) or Office 

of Drug Evaluation II (HFD–500), 

whichever is applicable,’’ and by adding 

in its place ‘‘Office of New Drugs’’ and 

in paragraph (f)(2)(iv) by removing 

‘‘Center for Drug Evaluation and 

Research’’ and by adding in its place 

‘‘Office of New Drugs’’. 

§ 314.125 [Amended] 

■ 6. Section 314.125 is amended in 

paragraph (b)(16) by removing ‘‘part 58’’ 

and by adding in its place ‘‘part 56’’. 

Dated: February 27, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy. 

[FR Doc. E9–4813 Filed 3–5–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 510 and 529 

[Docket No. FDA–2009–N–0665] 

New Animal Drugs; Change of 

Sponsor; Methoxyflurane 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect a 

change of sponsor for a new animal drug 

application (NADA) from ScheringPlough Animal Health, Inc., to Medical 

Developments International, Ltd. 

DATES: This rule is effective March 6, 

2009. 

FOR FURTHER INFORMATION CONTACT: 

David R. Newkirk, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8307, email: david.newkirk@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: ScheringPlough Animal Health Corp., 556 Morris 

Ave., Summit, NJ 07901, has informed 

FDA that it has transferred ownership 

of, and all rights and interest in, NADA 

14–485 for ANAFANE (methoxyflurane) 

Volatile Liquid for Inhalation 

Anesthesia to Medical Developments 

International, Ltd., P.O. Box 21, 

Sandown Village, 3171 VIC Australia. 

Medical Developments International, 

Ltd., is not currently listed in the animal 

drug regulations as a sponsor of an 

approved application. In addition, FDA 

has noticed that this new animal drug 

has not been previously codified in 21 

CFR part 529. Accordingly, the 

regulations are amended in 21 CFR 

510.600(c) to add entries for Medical 

Developments International, Ltd., and in 

21 CFR part 529 to add this new animal 

drug. 

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. 

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