This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

9759 

Vol. 74, No. 43 

Friday, March 6, 2009 

DEPARTMENT OF AGRICULTURE 

Rural Utilities Service 

7 CFR Part 1779 

Rural Housing Service 

7 CFR Part 3575 

Rural Business—Cooperative Service 

Rural Utilities Service 

7 CFR Parts 4279 and 4280 

Rural Business—Cooperative Service 

Rural Housing Service 

Rural Utilities Service 

7 CFR Part 5001 

[FR Doc. E9–3092] 

RIN 0570–AA65 

Rural Development Guaranteed Loans 

AGENCIES: Rural Business—Cooperative 

Service, Rural Housing Service, Rural 

Utilities Service, USDA. 

ACTION: Interim rule; delay of the 

effective date. 

SUMMARY: Rural Development is further 

delaying the effective date of the interim 

rule for Rural Development Guaranteed 

Loans, which was published on 

December 17, 2008, to June 1, 2009. The 

interim rule establishes a unified 

guaranteed loan platform for the 

enhanced delivery of four existing Rural 

Development guaranteed loan 

programs—Community Facility; Water 

and Waste Disposal; Business and 

Industry; and Rural Energy for America 

Program, formerly known as Renewable 

Energy Systems and Energy Efficiency 

Improvement Projects. 

DATES: The effective date of the interim 

rule, which was published on December 

17, 2008 [73 FR 76698], delayed until 

February 17, 2008 [74 FR 2823], delayed 

until March 9, 2009 [74 FR 7179], is 

further delayed until June 1, 2009. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Michael Foore, Rural Development, 

Business and Cooperative Programs, 

U.S. Department of Agriculture, 1400 

Independence Avenue, SW., Stop 3201, 

Washington, DC 20250–3201; e-mail: 

Michael.Foore@wdc.usda.gov; telephone 

(202) 690–4730. 

SUPPLEMENTARY INFORMATION: On 

January 16, 2009, Rural Development 

delayed the original effective date of the 

interim rule from January 16, 2009, to 

February 17, 2009, because there was 

insufficient time to correct a technical 

error in the interim rule before the 

interim rule became effective on January 

16, 2009. 

Subsequently, Rural Development 

again delayed the effective date of the 

interim rule from February 17, 2009, to 

March 9, 2009 [74 FR 7179, February 13, 

2009] allowing for public comments to 

extend the effective date to June 1, 2009. 

As stated in the Federal Register, Rural 

Development identified several 

administrative actions, including 

providing the best guidance to its field 

staff on the interim rule, it believed 

were necessary to occur prior to the 

February 17, 2009, effective date in 

order to ensure the successful 

implementation of the interim rule. 

Consequently, Rural Development 

determined that it was necessary to 

extend the effective date to June 1, 2009, 

in order to provide Rural Development 

the necessary time to implement these 

administrative actions. 

As noted in the February 13, 2009, 

Federal Register, Rural Development 

made this change to the effective date, 

as is provided for under the 

Administrative Procedures Act (5 U.S.C. 

553(b)(3)(B)), because: 

1. Implementing the interim rule on 

February 17, 2009, would have created 

substantial legal and operation risks to 

the affected programs because the rule 

contains certain flaws that must be 

corrected and would not have provided 

the Agency sufficient time to properly 

train field staff and make changes to IT 

systems critical to the implementation 

of these programs. These actions could 

not have been completed by February 

17, 2009. 

2. The two week extension would 

allow the public a reasonable 

opportunity to comment on this 

proposed extension of the effective date 

to June 1, 2009, and the Agency to 

consider such comments before making 

the decision to make such extension. 

3. Extending the effective date to June 

1, 2009, allows the Agency to finish the 

60-day review described in the January 

20, 2009, memo from the Assistant to 

the President and Chief of Staff, entitled 

‘‘Regulatory Review.’’ 

The public comment period on the 

Agency’s proposed June 1, 2009, 

effective date closed on February 20, 

2009. The Agency received three 

comment letters on the proposed 

extension of the effective date. None of 

the commenters suggested that the 

interim rule become effective prior to 

June 1, 2009. Two of the three 

commenters also submitted comments 

during the public comment period on 

the interim rule. Because the comments 

submitted by these commenters, address 

issues that are very similar to those 

included in comments submitted during 

the public comment period for the 

interim rule, the Agency will consider 

these issues when it considers the 

comments on the interim rule. 

Therefore, the effective of the interim 

rule is extended to June 1, 2009. 

Dated: March 3, 2009. 

William F. Hagy III, 

Acting Deputy Under Secretary, Rural 

Development. 

[FR Doc. E9–4839 Filed 3–5–09; 8:45 am] 

BILLING CODE 3410–XY–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 310 and 347 

[Docket No. FDA–1978N–0007] (Formerly 

Docket No. 78N–021A) 

RIN 0910–AF42 

Astringent Drug Products That 

Produce Aluminum Acetate; Skin 

Protectant Drug Products for Over-theCounter Human Use; Technical 

Amendment 

AGENCY: Food and Drug Administration, 

HHS. 

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1 In the 1982 ANPR, we stated that the Panel had 

concluded that aluminum sulfate is safe but that 

there were insufficient data to establish its 

effectiveness for use as a styptic pencil (47 FR 

39436 at 39447 and 39448). In the Federal Register 

of April 3, 1989 (54 FR 13490 at 13493), we stated 

that an apparent administrative error had occurred 

in that the Panel had voted to classify aluminum 

sulfate as GRASE and not misbranded for use in a 

styptic pencil. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: We (Food and Drug 

Administration (FDA)) are amending the 

final monograph (FM) for over-thecounter (OTC) skin protectant astringent 

drug products. This amendment 

clarifies that aluminum acetate 

solutions, produced by dissolving 

aluminum sulfate tetradecahydrate and 

calcium acetate monohydrate in powder 

or tablet form in water, are generally 

recognized as safe and effective 

(GRASE) and not misbranded as 

astringent drug products. The 

amendment also describes how 

manufacturers should relabel these 

products to comply with the FM. We are 

issuing this amendment in response to 

a citizen petition (CP) that we received 

from a manufacturer of OTC astringent 

drug products. This final rule is part of 

our ongoing review of OTC drug 

products. 

DATES: Effective Date: This regulation is 

effective March 6, 2009. 

Compliance Date: The compliance 

date for all products, regardless of 

annual sales, is September 6, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Matthew R. Holman, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, MS 5411, 

Silver Spring, MD 20993, 301–796– 

2090. 

SUPPLEMENTARY INFORMATION: 

I. What Is the Regulatory History of 

This Rulemaking? 

A. Advance Notice of Proposed 

Rulemaking (ANPR) 

We published an ANPR for certain 

OTC skin protectant drug products in 

the Federal Register on September 7, 

1982 (47 FR 39436) (the 1982 ANPR). In 

the 1982 ANPR, the agency reported 

that the Advisory Review Panel on OTC 

Miscellaneous External Drug Products 

(the Panel) recommended that we 

classify solutions containing 2.5 to 5 

percent aluminum acetate as GRASE for 

topical use as an astringent. The 1982 

ANPR includes the following terms 

when referring to this ingredient (47 FR 

39436 at 39444 through 39446): 

• ‘‘aluminum acetate’’ 

• ‘‘aluminum acetate solution’’ 

• ‘‘Burow’s solution’’ 

Although some of the aluminum 

acetate products that the Panel 

evaluated were powders and tablets that 

were dissolved in water (Refs. 1 and 2), 

those products, as manufactured, did 

not contain aluminum acetate. Rather, 

those powders and tablets contained 

aluminum sulfate and calcium acetate, 

which produced an aluminum acetate 

solution when dissolved in water. 

In addition, the Panel separately 

evaluated aluminum sulfate and 

calcium acetate as OTC astringent single 

active ingredients (i.e., when not in 

combination with each other). The 

Panel recommended that aluminum 

sulfate, as a single active ingredient, is 

GRASE and not misbranded only for use 

in a styptic pencil (47 FR 39436 at 

39447 and 39448).1 The Panel 

recommended that calcium acetate be 

classified as not GRASE or misbranded 

when used as a single active ingredient 

(47 FR 39436 at 39444). The Panel was 

not aware of any data demonstrating the 

safety and effectiveness of calcium 

acetate, as a single active ingredient, 

when used as an OTC astringent active 

ingredient in any formulation. 

B. Proposed Rule 

In the Federal Register of April 3, 

1989 (54 FR 13490), we published a 

proposed rule amending the tentative 

final monograph (TFM) for OTC skin 

protectant drug products to include 

astringent drug products (the 1989 

TFM). In the 1989 TFM, we proposed 

monograph status for aluminum acetate, 

as recommended by the Panel (54 FR 

13490 at 13494). However, we revised 

the Panel’s recommended concentration 

to 0.13 to 0.5 percent, indicating that the 

Panel did not take into account further 

dilution of the 2.5 to 5 percent 

aluminum acetate solution (54 FR 13490 

at 13494 and 13496). We agreed with 

the Panel’s recommendation for calcium 

acetate and proposed that the ingredient 

be classified as nonmonograph (54 FR 

13490 at 13496). We also noted that one 

comment mentioned that the USP 

(United States Pharmacopeia) procedure 

for preparing Burow’s Solution 

(aluminum acetate solution) de novo 

does not pertain to modified aluminum 

acetate solutions prepared from tablets 

or powders (54 FR 13490 at 13494). 

C. Final Rule 

In the Federal Register of October 21, 

1993 (58 FR 54458), we published a 

final rule in the form of a FM for OTC 

skin protectant drug products that 

established conditions under which 

OTC astringent drug products are 

GRASE and not misbranded (the 1993 

skin protectant FM). The 1993 skin 

protectant FM added GRASE astringent 

active ingredients and labeling for 

astringents to 21 CFR part 347 subpart 

A. The 1993 skin protectant FM, which 

became effective on October 21, 1994, 

includes 0.13 to 0.5 percent aluminum 

acetate as an active ingredient in 

§ 347.12 (21 CFR 347.12) (then 

§ 347.10(a) (21 CFR 347.10(a))). The 

1993 skin protectant FM specifies that, 

depending on the formulation and 

concentration of the marketed product, 

the manufacturer must provide adequate 

directions so that the resulting solution 

to be used by consumers contains 0.13 

to 0.5 percent aluminum acetate. 

In the 1993 skin protectant FM, we 

noted that calcium acetate was listed in 

§ 310.545(a)(18)(ii) (21 CFR 

310.545(a)(18)(ii)) as nonmonograph in 

a final rule published on May 10, 1993 

(58 FR 27636 at 27642). 

D. Feedback Letter 

A manufacturer submitted a letter in 

1994 requesting clarification whether its 

OTC astringent drug product, a powder 

containing aluminum sulfate and 

calcium acetate, could continue to be 

marketed under the 1993 skin protectant 

FM (Ref. 3). The manufacturer stated 

that it markets one of the products 

reviewed by the Panel in which 

aluminum acetate was determined to be 

GRASE for OTC astringent drug 

products. When dissolved in water 

according to labeled directions, the 

manufacturer’s product becomes an 

aluminum acetate solution with a 

calcium sulfate precipitate. 

In a 1995 letter to the manufacturer, 

we stated that the product fails to 

comply with the 1993 skin protectant 

FM because it contains the 

nonmonograph ingredient calcium 

acetate (Ref. 4). We suggested that the 

manufacturer contact us to amend the 

1993 skin protectant FM to allow 

continued marketing of its product. 

Subsequently, the manufacturer 

submitted a CP (Ref. 5). 

II. Why Is FDA Issuing This Document? 

We are issuing this technical 

amendment in response to the CP 

submitted by an OTC astringent drug 

product manufacturer in 1995 (the 1995 

CP) (Ref. 5). The 1995 CP was submitted 

by a manufacturer who marketed one of 

the products reviewed by the Panel in 

which aluminum acetate was 

determined to be GRASE for OTC 

astringent drug products (see section I.D 

of this document). The 1995 CP 

requested that we revise the skin 

protectant FM (§ 347.12(a) (then 

§ 347.10(a)) as follows, or in equivalent 

language having the same effect (Ref. 5): 

‘‘Aluminum acetate, 0.13 to 0.5 percent 

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(where the product as marketed consists 

of salts other than aluminum acetate, or 

where the aluminum acetate 

concentration of the product as 

marketed is other than 0.13 to 0.5 

percent, the manufacturer must provide 

adequate directions so that the resulting 

solution to be used by the consumer 

consists of 0.13 to 0.5 percent aluminum 

acetate).’’ The manufacturer intended 

‘‘salts other than aluminum acetate’’ to 

include dry formulations of aluminum 

sulfate plus calcium acetate. The 

manufacturer argued that its labeled 

directions produce an aluminum acetate 

solution that falls within the 

concentration range specified in the 

1993 skin protectant FM. 

We have not taken any enforcement 

action against these powder and tablet 

products that produce an aluminum 

acetate solution while developing this 

document as our response to the 1995 

CP. In this document, we are granting 

the request in the 1995 CP to revise the 

1993 skin protectant FM by including 

the combination of aluminum sulfate 

and calcium acetate in powder and 

tablet dosage forms to prepare an 

aluminum acetate solution. 

III. What Changes to the Skin 

Protectant FM Is FDA Making in This 

Document? 

This document adds the GRASE 

combination of aluminum sulfate 

tetradecahydrate and calcium acetate 

monohydrate in powder or tablet form 

to produce 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.’’ This technical amendment 

also includes additional labeling 

requirements for OTC astringent drug 

products that consist of this GRASE 

combination of active ingredients. 

Since we issued the 1993 skin 

protectant FM, the United States 

Pharmacopeia/National Formulary 

(USP/NF) has added monographs for 

• Aluminum Sulfate and Calcium 

Acetate Tablets for Topical Solution 

(Ref. 6) and 

• Aluminum Sulfate and Calcium 

Acetate for Topical Solution (Ref. 7). 

The second USP monograph is for 

products formulated as powders. The 

USP monographs state that these 

products contain aluminum sulfate 

tetradecahydrate and calcium acetate 

monohydrate, which are the hydrate 

forms of aluminum sulfate and calcium 

acetate. When a tablet or powder 

containing the aluminum sulfate 

tetradecahydrate and calcium acetate 

monohydrate is dissolved in water, a 

chemical reaction occurs that produces 

an aluminum acetate solution and a 

calcium sulfate precipitate. 

Rather than amend the aluminum 

acetate section of the 1993 skin 

protectant FM as requested in the 1995 

CP, we are redesignating existing 

§ 347.20(b) as § 347.20(c), and adding a 

new § 347.20(b), to include the 

combination of aluminum sulfate 

tetradecahydrate and calcium acetate 

monohydrate in powder and tablet 

dosage forms to prepare an aluminum 

acetate solution. We are limiting the 

combination of ingredients to powder 

and tablet dosage forms because there 

are corresponding USP monographs for 

these dosage forms, but not for other 

dosage forms (Refs. 6 and 7). New 

§ 347.20(b) states:‘‘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’.’’ This amendment provides 

an alternate approach to prepare the 

aluminum acetate solution described in 

§ 347.12(a). 

Marketed products have contained 

varying amounts of aluminum sulfate 

and calcium acetate based on the 

amount of water in which the powder 

or tablet is dissolved to make an 

aluminum acetate solution. For 

example, a product with directions to 

use 16 ounces of water requires a larger 

amount of each ingredient than a 

product with directions to use 12 

ounces of water. Generally, the products 

have contained between 53 and 59 

percent aluminum sulfate and 40 to 44 

percent calcium acetate in each tablet or 

powder. Inactive ingredients account for 

the other amounts to make 100 percent. 

Because of the varying amount of 

aluminum sulfate and calcium acetate, 

we are not specifying an amount for 

each active ingredient required in a 

product. However, this information is 

required to appear in the product’s 

labeling (see 21 U.S.C. 352(e)(1)(A)(ii) 

and § 201.66(c)(2) (21 CFR 

201.66(c)(2))). Labeling must state the 

amount of each active ingredient in the 

product and those amounts, when 

dissolved in the amount of water stated 

in the product’s labeling, must produce 

a 0.13 to 0.5 percent aluminum acetate 

solution. We are providing labeling in 

this document to allow manufacturers to 

continue to market these products in 

this manner. 

We are revising § 347.52 (Labeling of 

astringent drug products) (21 CFR 

347.52), which describes specific 

labeling for products containing 

aluminum sulfate tetradecahydrate and 

calcium acetate monohydrate in powder 

or tablet dosage forms (see Sample OTC 

Astringent Drug Product Label). 

‘‘Aluminum sulfate tetradecahydrate’’ 

and ‘‘calcium acetate monohydrate’’ 

must appear under the ‘‘Active 

ingredients’’ heading in Drug Facts, as is 

typical for OTC drug products. Under 

the ‘‘Purpose’’ heading, an asterisk 

should follow the word ‘‘Astringent’’. In 

addition, a statement explaining the 

asterisk should be included in the 

‘‘Active ingredients/Purpose’’ section: 

‘‘*When combined together in water, 

these ingredients form the active 

ingredient aluminum acetate. See 

Directions.’’ The ‘‘Directions’’ section 

should include instructions on 

preparing the aluminum acetate 

solution (0.13 to 0.5 percent) from the 

powder(s) or tablet(s). These directions 

will inform consumers that a solution is 

produced by dissolving the powder(s) or 

tablet(s) in water. We believe this 

labeling in the ‘‘Active ingredients/ 

Purpose’’ and ‘‘Directions’’ sections 

adequately informs consumers that 

aqueous aluminum acetate is acting as 

the astringent active ingredient. 

The combination product containing 

aluminum sulfate tetradecahydrate and 

calcium acetate monohydrate has the 

same indications and warnings as other 

monograph astringent products 

containing aluminum acetate. We are 

requiring that the ‘‘for use as a soak’’ 

and ‘‘for use as a compress or wet 

dressing’’ subheadings in the 

‘‘Directions’’ section appear in bold type 

to make it easier for consumers to read 

and follow the different parts of the 

directions for these products (see 

Sample OTC Astringent Drug Product 

Label). For consistency in labeling, we 

are also requiring that the same two 

subheadings in the ‘‘Directions’’ section 

of OTC aluminum acetate solution drug 

products described in § 347.12(a) appear 

in bold type. The information under 

these subheadings for both types of 

aluminum acetate drug products (i.e., 

dry and solution formulations) is still 

required to appear in a bulleted format 

(see § 347.52(d)(1)(i) and (d)(1)(ii)). 

The following sample OTC astringent 

drug product label illustrates the 

labeling for products containing 

aluminum sulfate tetradecahydrate and 

calcium acetate monohydrate in powder 

or tablet dosage forms to produce an 

aluminum acetate solution: 

BILLING CODE 4160–01–S 

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BILLING CODE 4160–01–C 


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2The annual PPI for pulp, paper, and allied 

products (the major cost driver for labeling) rose 

from 174.1 to 202.6 between 1998 and 2005 (see 

http://data.bls.gov/cgi-bin/surveymost). We have 

verified the Web site address, but we are not 

responsible for subsequent changes to the Web site 

after this document publishes in the Federal 

Register. 

This sample label includes the specific 

labeling required for these products in 

this technical amendment as well as the 

general labeling required by the 1993 

skin protectant FM. The format and 

sequence of the information and the font 

sizes for the title, heading, subheadings, 

text, and other graphic features must be 

in accordance with § 201.66. 

In addition to adding new § 347.20(b), 

we are revising § 310.545(a)(18)(ii), 

which currently lists calcium acetate as 

a nonmonograph active ingredient that 

cannot be included in OTC astringent 

drug products. That section now reads 

as follows: ‘‘Calcium acetate (except 

calcium acetate monohydrate when 

combined with aluminum sulfate 

tetradecahydrate to provide an 

aluminum acetate solution as described 

in § 347.20(b)).’’ Therefore, calcium 

acetate is still nonmonograph except in 

products marketed under new 

§ 347.20(b). 

Because this document adds new 

§ 347.20(b), we are redesignating 

existing § 347.20(b), (c), and (d) as 

§ 347.20(c), (d), and (e), respectively. We 

are also revising the warnings in 21 CFR 

347.50(c) to reflect the Drug Facts 

format in § 201.66, while not changing 

the meaning of these warnings. The 

Sample OTC Astringent Drug Product 

Label reflects all of these revisions. 

IV. Analysis of Impacts 

We have examined the impacts of this 

final 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). We conclude 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. Because only a limited number 

of products will need to be relabeled, 

we certify that this final rule will not 

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 $130 

million, using the most current (2007) 

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. 

The purpose of this final rule is to 

amend the 1993 skin protectant FM to 

add the combination of aluminum 

sulfate tetradecahydrate and calcium 

acetate monohydrate for products that 

include appropriate amounts of these 

ingredients and adequate directions to 

produce an aluminum acetate solution 

within the monograph concentration 

range. This amendment describes a 

methodology for manufacturers of these 

OTC astringent drug products to relabel 

their products and market them in 

compliance with the 1993 skin 

protectant FM. 

We have identified two OTC skin 

protectant astringent drug products, 

each with several stockkeeping units 

(SKUs) (individual products, packages, 

and sizes), that may need to be 

relabeled. While we are aware of several 

other products that are no longer 

marketed, there may be a few marketed 

products of which we are not currently 

aware. Accordingly, we estimate that 

there may be 5 products with 5 to 10 

SKUs that may be affected by this final 

rule. 

We have updated the weighted 

average cost to relabel that we estimated 

for the final rule requiring uniform label 

formats of OTC drug products (64 FR 

13254 at 13279 to 13281, March 17, 

1999) (i.e., $3,600 x 1.1642 = $4,190 per 

SKU). Assuming up to 10 affected OTC 

SKUs in the marketplace, total one-time 

costs of relabeling could be $41,900 (i.e., 

10 x $4,190). Because frequent labeling 

redesigns are a recognized cost of doing 

business in the OTC drug industry, 

these costs may be less. Manufacturers 

that make voluntary market-driven 

changes to their labeling during the 

implementation period can implement 

the regulatory requirements for a 

nominal cost. All products, including 

those with annual sales less than 

$25,000, will have 18 months following 

publication of the final rule to comply 

with the 1993 skin protectant FM. 

Therefore, many of the labeling 

revisions may be done in the normal 

course of business. These steps should 

help to minimize the impact on small 

entities by providing enough time for 

implementation to enable entities to use 

up existing labeling stock. In addition, 

the final rule does not require any new 

reporting or recordkeeping activities. 

This final rule also requires 

manufacturers of the aluminum acetate 

solution products described in 

§ 347.12(a) to make two very minor 

changes in the labeling of their 

products. They will need to change the 

two ‘‘for use’’ subheadings in the 

directions from standard to bold type 

and should be able to do so at a 

negligible cost. We estimate that less 

than 10 SKUs will be affected by this 

minor change. This final rule will not 

impose a significant economic burden 

on affected entities. Therefore, we 

certify that this final 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)). 

V. 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)). 

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. Federalism 

We have analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. We have 

determined that the rule will have 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 

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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 Federal Food, Drug, 

and Cosmetic Act (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 imposing 

requirements related to the regulation of 

nonprescription drug products. (See 

section 751(b) through (e) of the act for 

the scope of the express preemption 

provision, the exemption procedures, 

and the exceptions to the provision.) 

This final rule clarifies that OTC 

astringent drug products containing 

aluminum sulfate tetradecahydrate and 

calcium acetate monohydrate in powder 

or tablet form for dissolving in water to 

produce an aluminum acetate solution 

are GRASE and not misbranded. The 

final rule also describes how 

manufacturers should relabel these 

products to comply with the 1993 skin 

protectant FM. Although this final rule 

would have a preemptive effect, in that 

it would preclude States from issuing 

requirements related to these OTC 

astringent 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 U.S. 861 

(2000). 

We believe that the preemptive effect 

of the final rule would be 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 

through publication of the 1993 skin 

protectant FM. We received no 

comments from any States on the final 

rulemaking. 

In addition, on December 17, 2008, 

FDA’s Division of Federal and State 

Relations provided notice via fax and email transmission to elected officials of 

State governments and their 

representatives of national 

organizations. The notice provided the 

States with further opportunity for input 

on the rule. It advised the States of the 

publication of the final rule and 

encouraged State and local governments 

to review the notice and to provide any 

comments to the docket (Docket No. 

1978N–0021A), by a date 30 days from 

the date of the notice (i.e., by January 

16, 2009), or to contact certain named 

individuals. We did not receive any 

comments in response to this notice. 

The notice has been filed in the abovenumbered docket. 

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. 

VIII. References 

The following references are on 

display in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852, under 

Docket No. FDA–1978N–0007 (formerly 

Docket No. 1978N–021A) and may be 

seen by interested persons between 9 

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

Friday. 

1. Bluboro product label, Appendix A to 

CP1. 

2. Domeboro product label. 

3. Letter from S. Buxbaum, Allergan, to R. 

Heller, FDA, dated January 24, 1994, 

Appendix C to CP1. 

4. Letter from B. Williams, FDA, to T. 

Mead, Allergan, dated January 2, 1995, 

Appendix D to CP1. 

5. CP1. 

6. The United States Pharmacopeia 31- 

National Formulary 26, The United States 

Pharmacopeial Convention, Inc., Rockville, 

MD, pp. 1360, 2008. 

7. The United States Pharmacopeia 31- 

National Formulary 26, The United States 

Pharmacopeial Convention, Inc., Rockville, 

MD, p. 1359, 2008. 

List of Subjects 

21 CFR Part 310 

Administrative practice and 

procedures, Drugs, Labeling, Medical 

devices, Reporting and recordkeeping 

requirements. 

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 parts 310 

and 347 are amended as follows: 

PART 310—NEW DRUGS 

■ 1. The authority citation for 21 CFR 

part 310 continues to read as follows: 

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

353, 355, 360b–360f, 360j, 361(a), 371, 374, 

375, 379e; 42 U.S.C. 216, 241, 242(a), 262, 

263b–263n. 

■ 2. Section 310.545 is amended by 

revising the entry for calcium acetate in 

paragraph (a)(18)(ii), by revising 

paragraph (d) introductory text and 

paragraph (d)(11), and by adding new 

paragraph (d)(39) to read as follows: 

§ 310.545 Drug products containing 

certain active ingredients offered over-thecounter (OTC) for certain uses. 

(a) * * * 

(18) * * * 

(ii) * * * 

* * * * * 

Calcium acetate (except calcium acetate 

monohydrate when combined with 

aluminum sulfate tetradecahydrate to 

provide an aluminum acetate solution 

as described in § 347.20(b)) of this 

chapter 

* * * * * 

(d) Any OTC drug product that is not 

in compliance with this section is 

subject to regulatory action if initially 

introduced or initially delivered for 

introduction into interstate commerce 

after the dates specified in paragraphs 

(d)(1) through (d)(39) of this section. 

* * * * * 

(11) November 10, 1993, for products 

subject to paragraphs (a)(8)(ii), (a)(10)(v) 

through (a)(10)(vii), (a)(18)(ii) (except 

products that contain ferric subsulfate 

as covered by paragraph (d)(22) of this 

section and except products that contain 

calcium acetate monohydrate as covered 

by paragraph (d)(39) of this section) 

through (a)(18)(v)(A), (a)(18)(vi)(A), 

(a)(22)(ii), (a)(23)(i), (a)(24)(i), and 

(a)(25) of this section. 

* * * * * 

(39) September 6, 2010, for products 

subject to paragraph (a)(18)(ii) of this 

section that contain calcium acetate 

monohydrate, except as provided in 

§ 347.20(b) of this chapter. 

PART 347—SKIN PROTECTANT DRUG 

PRODUCTS FOR OVER-THECOUNTER HUMAN USE 

■ 3. The authority citation for 21 CFR 

part 347 continues to read as follows: 

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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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