2080 Federal Register / Vol. 74, No. 9 / Wednesday, January 14, 2009 / Notices 

Record Retention Requirements for the 

Soy Protein and Risk of Coronary Heart 

Disease Health Claim—(OMB Control 

Number 0910–0428—Extension) 

Section 403(r)(3)(A)(i) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

343(r)(3)(A)(i)) provides for the use of 

food label statements characterizing a 

relationship of any nutrient of the type 

required to be in the label or labeling of 

the food to a disease or a health-related 

condition only where that statement 

meets the requirements of the 

regulations issued by the Secretary of 

Health and Human Services to authorize 

the use of such a health claim. Section 

101.82 (§ 101.82) of FDA’s regulations 

authorizes a health claim for food labels 

about soy protein and the risk of 

coronary heart disease. To bear the soy 

protein/coronary heart disease health 

claim, foods must contain at least 6.25 

grams of soy protein per reference 

amount customarily consumed. 

Analytical methods for measuring total 

protein can be used to quantify the 

amount of soy protein in foods that 

contain soy as the sole source of protein. 

However, at the present time there is no 

validated analytical methodology 

available to quantify the amount of soy 

protein in foods that contain other 

sources of protein. For these latter 

foods, FDA must rely on information 

known only to the manufacturer to 

assess compliance with the requirement 

that the foods contain the qualifying 

amount of soy protein. Thus, FDA 

requires manufacturers to have and keep 

records to substantiate the amount of 

soy protein in a food that bears the 

health claim and contains sources of 

protein other than soy, and to make 

such records available to appropriate 

regulatory officials upon written 

request. The information collected 

includes nutrient databases or analyses, 

recipes or formulations, purchase orders 

for ingredients, or any other information 

that reasonably substantiates the ratio of 

soy protein to total protein. 

In the Federal Register of October 23, 

2008 (73 FR 63157), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per 

Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

101.82(c)(2)(ii)(B) 25 1 25 1 25 

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

Based upon the agency’s experience 

with the use of health claims, FDA 

estimates that only about 25 firms 

would be likely to market products 

bearing a soy protein/coronary heart 

disease health claim and that only, 

perhaps, one of each firm’s products 

might contain non-soy sources of 

protein along with soy protein. The 

records required to be retained by 

§ 101.82(c)(2)(ii)(B) are the records, e.g., 

the formulation or recipe, that a 

manufacturer has and maintains as a 

normal course of its doing business. 

Thus, the burden to the food 

manufacturer is that involved in 

assembling and providing the records to 

appropriate regulatory officials for 

review or copying. 

Dated: January 7, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–573 Filed 1–13–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0653] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Filing Objections 

and Requests for a Hearing on a 

Regulation or Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

requirements for filing objections and 

requests for a hearing on a regulation or 

order. 

DATES: Submit written or electronic 

comments on the collection of 

information by March 16, 2009. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

SUPPLEMENTARY INFORMATION: 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, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 


sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 74, No. 9 / Wednesday, January 14, 2009 / Notices 2081 

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. 

Filing Objections and Requests for a 

Hearing on a Regulation or Order—21 

CFR Part 12 (OMB Control Number 

0910–0184)—Extension 

The regulations in 21 CFR 12.22, 

issued under section 701(e)(2) of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 371(e)(2)), set forth 

the instructions for filing objections and 

requests for a hearing on a regulation or 

order under § 12.20(d) (21CFR 12.20(d)). 

Objections and requests must be 

submitted within the time specified in 

§ 12.20(e). Each objection, for which a 

hearing has been requested, must be 

separately numbered and specify the 

provision of the regulation or the 

proposed order. In addition, each 

objection must include a detailed 

description and analysis of the factual 

information and any other document, 

with some exceptions, supporting the 

objection. Failure to include this 

information constitutes a waiver of the 

right to a hearing on that objection. FDA 

uses the description and analysis to 

determine whether a hearing request is 

justified. The description and analysis 

may be used only for the purpose of 

determining whether a hearing has been 

justified under 21 CFR 12.24 and do not 

limit the evidence that may be 

presented if a hearing is granted. 

Respondents to this information 

collection are those parties that may be 

adversely affected by an order or 

regulation. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

12.22 5 1 5 20 100 

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

The burden estimate for this 

collection of information is based on 

past filings. Agency personnel, 

responsible for processing the filing of 

objections and requests for a public 

hearing on a specific regulation or order, 

estimate approximately five requests are 

received by the agency annually, with 

each requiring approximately 20 hours 

of preparation time. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Dated: January 7, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–574 Filed 1–13–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Pulmonary-Allergy Drugs Advisory 

Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: PulmonaryAllergy Drugs Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on February 4, 2009, from 8:30 a.m. 

to 5 p.m. 

Location: Hilton Washington DC 

North/ Gaithersburg, The Ballrooms, 

620 Perry Pkwy., Gaithersburg, MD. The 

hotel telephone number is 301–977– 

8900. 

Contact Person: Kristine T. Khuc, 

Center for Drug Evaluation and Research 

(HFD–21), Food and Drug 

Administration, 5630 Fishers Lane (for 

express delivery, 5630 Fishers Lane,rm. 

1093), Rockville, MD 20857, 301–827– 

7001, Fax: 301–827–6776, e-mail: 

Kristine.Khuc@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512545. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: The committee will discuss 

biologics license application (BLA) No. 

125277, KALBITOR, for ecallantide 

injection by Dyax Corp., for the 

proposed indication of treatment of 

acute attacks of hereditary angioedema. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

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

dockets/ac/acmenu.htm, click on the 


sroberts on PROD1PC70 with NOTICES