41438 Federal Register / Vol. 74, No. 157 / Monday, August 17, 2009 / Notices 

mg/mL), was not withdrawn from sale 

for reasons of safety or effectiveness. 

The petitioner identified no data or 

other information suggesting that 

DEMADEX (torsemide) injection, 20 mg/ 

2 mL (10 mg/mL) and 50 mg/5 mL (10 

mg/mL), was withdrawn for reasons of 

safety or effectiveness. FDA has 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events and has 

found no information that would 

indicate that this product was 

withdrawn from sale for reasons of 

safety or effectiveness. Accordingly, the 

agency will continue to list DEMADEX 

(torsemide) injection, 20 mg/2 mL (10 

mg/mL) and 50 mg/5 mL (10 mg/mL), in 

the ‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to DEMADEX (torsemide) injection, 20 

mg/2 mL (10 mg/mL) and 50 mg/5 mL 

(10 mg/mL), may be approved by the 

agency if all other legal and regulatory 

requirements for the approval of ANDAs 

are met. If FDA determines that labeling 

for this drug product should be revised 

to meet current standards, the agency 

will advise ANDA applicants to submit 

such labeling. 

Dated: August 7, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–19641 Filed 8–14–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0268] 

Draft Guidance for Industry: Labeling 

of Certain Beers Subject to the 

Labeling Jurisdiction of the Food and 

Drug Administration; Availability; 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance 

document entitled ‘‘Guidance for 

Industry: Labeling of Certain Beers 

Subject to the Labeling Jurisdiction of 

the Food and Drug Administration.’’ 

This guidance, when finalized, will 

provide industry with information on 

how to label beers that are subject to 

FDA’s labeling laws and regulations. 

This draft guidance is being issued in 

light of the recent ruling by the Alcohol 

and Tobacco Tax and Trade Bureau 

(TTB) (formerly The Bureau of Alcohol, 

Tobacco, and Firearms (ATF)) clarifying 

that certain beers do not meet the 

definition of a ‘‘malt beverage’’ under 

the Federal Alcohol Administration Act 

(FAA Act). Because these beers are not 

subject to the labeling provisions of the 

FAA Act, they are subject to the labeling 

provisions of the Federal Food, Drug, 

and Cosmetic Act (FD&C Act) and the 

Fair Packaging and Labeling Act (FPLA). 

FDA, in this draft guidance, also 

reminds manufacturers that the labeling 

of wine beverages containing less than 

7 percent alcohol by volume, such as 

wine coolers, diluted wine beverages, 

dealcoholized or partially dealcoholized 

wine and ciders, is also subject to FDA 

labeling requirements. FDA is also 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the agency. 

DATES: Submit written or electronic 

comments on the draft guidance at any 

time. Submit written or electronic 

comments on the proposed collection of 

information by October 16, 2009. 

ADDRESSES: Submit written comments 

on this draft guidance, including 

comments regarding the proposed 

collection of information, to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Submit electronic comments 

on the draft guidance, including 

comments regarding the proposed 

collection of information, to http:// 

www.regulations.gov. Submit written 

requests for single copies of the draft 

guidance to Office of Nutrition, Labeling 

and Dietary Supplements, Center for 

Food Safety and Applied Nutrition 

(HFS–800), Food and Drug 

Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740. Send 

two self-addressed adhesive labels to 

assist that office in processing your 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance. 

FOR FURTHER INFORMATION CONTACT: 

With regard to the draft guidance: 

Loretta A. Carey, Center for Food 

Safety and Applied Nutrition (HFS– 

820), Food and Drug 

Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 

301–436–2371. 

With regard to the proposed collection 

of information: Jonna Capezzuto, 

Office of Information Management 

(HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796– 

3794. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

the draft guidance entitled ‘‘Guidance 

for Industry: Labeling of Certain Beers 

Subject to the Labeling Jurisdiction of 

the Food and Drug Administration.’’ 

This guidance, when finalized, will 

provide industry with information on 

how to label beers that are subject to 

FDA’s labeling laws and regulations. 

FDA, in this draft guidance, also 

reminds manufacturers that the labeling 

of wine beverages containing less than 

7 percent alcohol by volume, such as 

wine coolers, diluted wine beverages, 

dealcoholized or partially dealcoholized 

wine and ciders, is also subject to FDA 

labeling requirements (Ref. 1). 

As reflected in the 1987 

Memorandum of Understanding 

between FDA and TTB’s predecessor 

agency, the ATF (Ref. 2), TTB is 

responsible for the issuance and 

enforcement of regulations with respect 

to the labeling of distilled spirits, wines, 

and malt beverages under the FAA Act. 

TTB recently clarified that certain 

beers, which are not made from both 

malted barley and hops but are instead 

made from substitutes for malted barley 

(such as sorghum, rice or wheat), or are 

made without hops do not meet the 

definition of a malt beverage under the 

FAA Act (see TTB Ruling 2008–3) (Ref. 

3). TTB stated in its ruling that such 

products (other than sake, which is 

classified as a wine under the FAA Act) 

are not subject to the labeling, 

advertising, and other provisions of the 

TTB regulations issued under the FAA 

Act. Therefore, these beers are subject to 

the labeling requirements under FDA’s 

laws and regulations. However, as 

explained in the TTB ruling, some TTB 

labeling requirements such as the 

Government Health Warning Statement 

under the Alcoholic Beverage Labeling 

Act and certain marking requirements 

under the Internal Revenue Code 

continue to apply to these products. 

This draft guidance is intended to 

assist manufacturers in labeling beers 

that are subject to FDA’s labeling laws 

and regulations. In general, FDA 

requires that food products under its 

labeling jurisdiction be truthfully and 

informatively labeled in accordance 

with the FD&C Act and the FPLA, and 

FDA’s implementing regulations. These 

FDA labeling requirements are 

explained in the draft guidance 

document. 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 74, No. 157 / Monday, August 17, 2009 / Notices 41439 

FDA is issuing this draft guidance as 

a level 2 guidance consistent with 

FDA’s good guidance practices 

regulation (21 CFR 10.115). This draft 

guidance represents the agency’s current 

thinking on this topic. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statues 

and regulations. 

II. Paperwork Reduction Act of 1995 

Under the PRA (44 U.S.C. 3501– 

3520), Federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Title: Labeling of Certain Beers Subject 

to the Labeling Jurisdiction of the Food 

and Drug Administration (OMB Control 

Number 0910–NEW) 

This draft guidance is intended to 

assist manufacturers in labeling beers 

that are subject to FDA’s labeling laws 

and regulations. All labeling regulations 

discussed in this draft guidance have 

been previously approved by OMB in 

accordance with the PRA under OMB 

Control No. 0910–0381. The regulations 

approved under OMB Control No. 0910– 

0381 include §§ 101.3, 101.4, 101.5, 

101.9, 101.22, and 101.105 (21 CFR 

101.3, 101.4, 101.5, 101.9, 101.22, and 

101.105). The proposed information 

collection seeks to add manufacturers of 

certain beers that do not meet the 

definition of a ‘‘malt beverage’’ under 

the FAA Act as new respondents to 

these labeling regulations. The proposed 

information collection also seeks OMB 

approval of allergen labeling of these 

beers under section 403(w)(1) of the 

FD&C Act (21 U.S.C. 343(w)(1)), which 

was added by the Food Allergen 

Labeling and Consumer Protection Act 

of 2004 (FALCPA). 

Section 101.3 of FDA’s food labeling 

regulations requires that the label of a 

food product in packaged form bear a 

statement of identity, (i.e., the name of 

the product), including, as appropriate, 

the form of the food or the name of the 

food imitated. Section 101.4 prescribes 

the requirements for the declaration of 

ingredients on the label or labeling of 

food products in packaged form, 

including using the common or usual 

name of each ingredient. Section 101.5 

requires that the label of a food product 

in packaged form specify the name and 

place of business of the manufacturer, 

packer, or distributor and, if the food 

producer is not the manufacturer of the 

food product, its connection with the 

food product. Section 101.9 requires 

that nutrition information be provided 

for all food products intended for 

human consumption and offered for 

sale, unless an exemption in § 101.9(j) 

applies to the product. Section 101.22 

contains labeling requirements for the 

disclosure of spices, flavorings, 

colorings, and chemical preservatives 

(§ 101.22(j)) in food products. Section 

101.105 specifies requirements for the 

declaration of the net quantity of 

contents on the label of a food in 

packaged form. 

Under the FD&C Act, as amended by 

the FALCPA, the food source name of 

any ‘‘major food allergen’’ present must 

be declared (section 403(w)(1) of the 

FD&C Act, (21 U.S.C. 343(w)(1))). 

Section 201(qq) of the FD&C Act, (21 

U.S.C. 321(qq)), defines ‘‘major food 

allergen’’ as milk, egg, fish, Crustacean 

shellfish, tree nuts, wheat, peanuts, and 

soybeans, as well as any food ingredient 

that contains protein derived from one 

of them, with the exception of highly 

refined oils. 

Description of respondents: The 

respondents to this collection of 

information are manufacturers of beers 

that are subject to FDA’s labeling laws 

and regulations. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Citation No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

21 CFR 101.3 and 101.22 12 2 24 .5 12 

21 CFR 101.4 12 2 24 1 24 

21 CFR 101.5 12 2 24 0.25 6 

21 CFR 101.9 12 2 24 4 96 

21 CFR 101.105 12 2 24 0.5 12 

Section 403(w)(1) of the Federal Food, 

Drug, and Cosmetic Act 12 2 24 1 24 

Guidance Document, ‘‘Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration’’ 12 1 12 1 12 

mstockstill on DSKH9S0YB1PROD with NOTICES

41440 Federal Register / Vol. 74, No. 157 / Monday, August 17, 2009 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

Citation No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Total 186 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

FDA’s estimate of the number of 

respondents in table 1 is based on the 

number of regulatory submissions 

submitted to TTB for beers that do not 

meet the definition of a ‘‘malt beverage’’ 

under the FAA Act. Based on its records 

of submissions received from 

manufacturers of such products, TTB 

estimates the number of respondents to 

be 12 and the number of submissions 

annually to be 25. Thus, FDA adopts 

TTB’s estimate of 12 respondents, and 

an annual frequency per response of 2, 

in table 1 of this document. 

FDA’s estimate of the hours per 

response for each regulation is based on 

FDA’s experience with food labeling 

under the agency’s jurisdiction. The 

estimated hours per response for 

§§ 101.3, 101.4, 101.5, 101.9, 101.22, 

and 101.105 in table 1 of this document 

are equal to, and based upon, the 

estimated hours per response approved 

by OMB in OMB Control No. 0910– 

0381. FDA further estimates that the 

labeling burden of section 403(w)(1) of 

the FD&C Act, which specifies 

requirements for the declaration of food 

allergens, will be 1 hour based upon the 

similarity of the requirements to that of 

§ 101.4. Finally, FDA estimates that a 

respondent will spend 1 hour reading 

the guidance document, once finalized. 

Thus, FDA estimates that 12 

respondents will each label two 

products annually, for a total of 24 

labels. FDA estimates that the 

manufacturers will spend 7.25 hours 

(0.5 hours + 1 hour + 0.25 hour + 4 

hours + 0.5 hour + 1 hour = 7.25 hours) 

on each label to comply with FDA’s 

labeling regulations and the 

requirements of section 403(w)(1), for a 

total of 174 hours (24 labels x 7.25 hours 

= 174 hours). In addition, 12 

respondents will each spend 1 hour 

reading the guidance document, for a 

total of 12 hours. Thus, FDA estimates 

the total hour burden of the proposed 

collection of information to be 186 

hours (174 hours + 12 hours = 186 

hours). 

Before the proposed information 

collection provisions contained in this 

draft guidance become effective, FDA 

will publish a notice in the Federal 

Register announcing OMB’s decision to 

approve, modify, or disapprove the 

information collection provisions. An 

agency may not conduct or sponsor, and 

a person is not required to respond to, 

a collection of information unless it 

displays a currently valid OMB control 

number. 

This draft guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 

§§ 101.3, 101.4, 101.5, 101.9, 101.22, 

and 101.105 have been approved under 

OMB Control No. 0910–0381. 

III. Comments 

Interested persons may submit written 

or electronic comments regarding this 

draft guidance document, including 

comments regarding the proposed 

collection of information. Written 

comments should be submitted to the 

Division of Dockets Management (see 

ADDRESSES). Electronic comments 

should be submitted to http:// 

www.regulations.gov. Submit a single 

copy of electronic comments or two 

paper copies of any mailed comments, 

except that individuals may submit one 

paper copy. Comments are to be 

identified with the docket number 

found in brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

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

Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at http:// 

www.fda.gov/FoodGuidances. 

V. References 

We have placed the following 

references on display in the Division of 

Dockets Management (see ADDRESSES). 

The references may be seen between 9 

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

Friday. FDA has verified the Web site 

addresses, but it is not responsible for 

any subsequent changes to the Web site 

addresses after this document publishes 

in the Federal Register. 

1. FDA Compliance Policy Guide (CPG) 

7101.04 (Dealcoholized Wine and Malt 

Beverages- Labeling), available at http:// 

www.fda.gov/ICECI/ComplianceManuals/ 

CompliancePolicyGuidanceManual/ 

ucm074430.htm and CPG 7101.05 (Labeling 

—Diluted Wines and Cider with Less Than 

7% Alcohol), available at http:// 

www.fda.gov/ICECI/ComplianceManuals/ 

CompliancePolicyGuidanceManual/ 

ucm074431.htm. 

2. Memorandum of Understanding 225– 

88–2000 between FDA and Bureau of 

Alcohol, Tobacco and Firearms, available at 

http://www.fda.gov/AboutFDA/Partnerships

Collaborations/MemorandaofUnderstanding

MOUs/DomesticMOUs/ucm116370.htm. 

3. TTB Ruling 2008–3 dated July 7, 2008, 

available at http://www.fda.gov/AboutFDA/ 

PartnershipsCollaborations/Memorandaof

UnderstandingMOUs/DomesticMOUs/ 

ucm116370.htm. 

Dated: August 11, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–19640 Filed 8–14–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

Federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301/ 

496–7057; fax: 301/402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

Development of a New Carbohydrate 

Antibody to GalNac1–3Gal 

Description of Technology: The 

present invention provides a 

monoclonal antibody that binds 

mstockstill on DSKH9S0YB1PROD with NOTICES