69344 Federal Register / Vol. 70, No. 219 / Tuesday, November 15, 2005 / Notices 

evaluation of the effectiveness of ORR 

employability services through RSS and 

TAG, and (2) propose options for 

institutionalizing ongoing evaluation 

and performance assessment into the 

programs. ORR is requesting OMB 

clearance for three methods of 

information collection: (1) Interviews 

with state and local refugee program 

administrators and service providers in 

three sites to learn about service 

delivery and organizational 

arrangements, and with a small number 

of local employers who work with RSSand TAG-funded service providers to 

learn about their experiences with the 

programs; (2) a sample of 1,125 refugees 

to collect data on refugees’ employment 

an earnings outcomes; (3) two to four 

focus groups with seven to ten program 

clients in each of the three sites to 

obtain customer perspectives of the 

services they received and their 

adjustment experiences. 

Respondents 

(1) Interviews will be conducted with 

three state refugee coordinators, 

voluntary agency (VOLAG) and Mutual 

Assistance Association (MAA) staff, 

local RSS and TAG service providers, 

and employers who employ significant 

numbers of refugees. 

(2) The respondents of the survey are 

refugees who have been in the United 

States for fewer than five years, and, 

thus, are eligible for RSS and TAG 

services. The survey relies on a mixedmode data collection method that 

involves both telephone and in-person 

interviews. If individuals cannot be 

reached by phone, an attempt will be 

made to contact them in person. 

Approximately 900 of the 1,125 refugees 

sampled will complete the survey over 

a nine-week period. 

(3) Respondents of the focus groups 

will include refugees who have received 

RSS- and TAG-funded services. 

Approximately 70 refugees will 

participate in the focus groups. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Interviews with program staff ......................................................................... 60 1 1 60 

Interviews with employers ............................................................................. 12 1 2 24 

Survey of refugees ........................................................................................ 900 1 0 .75 675 

Focus group with program clients ................................................................. 70 1 2 140 

Estimated Total Annual Burden 

Hours: 899. 

Additional Information 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: Office of 

Management and Budget, Paperwork 

Reduction Project, Attn: Desk Officer for 

ACF, E-mail address: 

Katherine_T._Astrich@omb.eop.gov. 

Dated: November 8, 2005. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 05–22625 Filed 11–14–05; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0317] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Record Retention 

Requirements for the Soy Protein and 

Risk of Coronary Heart Disease Health 

Claim 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by December 

15, 2005. 

ADDRESSES: OMB is still experiencing 

significant delays in the regular mail, 

including first class and express mail, 

and messenger deliveries are not being 

accepted. To ensure that comments on 

the information collection are received, 

OMB recommends that comments be 

faxed to the Office of Information and 

Regulatory Affairs, OMB, Attn: Fumie 

Yokota, Desk Officer for FDA, FAX: 

202–395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Record Retention Requirements for the 

Soy Protein and Risk of Coronary Heart 

Disease Health Claim—21 CFR 

101.82(c)(2)(ii)(B) (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 (21 CFR 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 

Federal Register / Vol. 70, No. 219 / Tuesday, November 15, 2005 / Notices 69345 

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 food 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 data bases 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 August 23, 

2005 (70 FR 49295), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. One comment was received 

that was not related to the information 

collection. 

FDA estimates the burden of the 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR section Number of respondents Annual frequency 

per response Total annual responses Hours per response Total hours 

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

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

Based upon its 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 nonsoy 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: November 8, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–22636 Filed 11–14–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0424] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approval; 

Survey on Program Funding 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a collection of information entitled 

‘‘Survey on Program Funding’’ has been 

approved by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–4659. 

SUPPLEMENTARY INFORMATION: 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. OMB has now approved the 

information collection and has assigned 

OMB control number 0910–0574. The 

approval expires on April 30, 2006. A 

copy of the supporting statement for this 

information collection is available on 

the Internet at http://www.fda.gov/ 

ohrms/dockets. 

Dated: November 8, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–22637 Filed 11–14–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Request for Nominations for 

Nonvoting Member Representing 

Industry Interests on a Public Advisory 

Committee; Nonprescription Drugs 

Advisory Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for a nonvoting industry 

representative to serve on the 

Nonprescription Drugs Advisory 

Committee. 

DATES: All letters of interest and 

nominations should be received on or 

before December 15, 2005. 

ADDRESSES: Letters of intent and 

nominations for membership should be 

submitted to Jayne Peterson (see FOR

FURTHER INFORMATION CONTACT). 

FOR FURTHER INFORMATION CONTACT: 

Jayne Peterson, Advisors and 

Consultants Staff (HFD–21), Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 5600 Fishers 

Lane (for express delivery, 5630 Fishers 

Lane, rm. 1093), Rockville, MD 20857, 

301–827–7001, e-mail: 

petersonj@cder.fda.gov. 

SUPPLEMENTARY INFORMATION: The 

agency requests nominations for a 

nonvoting industry representative to 

serve on the Nonprescription Drugs 

Advisory Committee. 

I. Function 

The function of the committee is to 

review and evaluate available data 

concerning the safety and effectiveness 

of over-the-counter (nonprescription) 

human drug products for use in the 

treatment of a broad spectrum of human 

symptoms and diseases. 

II. Selection Procedure 

Any industry organization interested 

in participating in the selection of an 

appropriate nonvoting member to 

represent industry interests should send 

a letter stating that interest to the FDA 

contact (see FOR FURTHER INFORMATION

CONTACT) within 30 days of publication 

of this notice. Within the subsequent 30 

days, FDA will send a letter to each 

organization that has expressed an 

interest, attaching a complete list of all 

such organizations; and a list of all 

nominees along with their current 

resumes. The letter will also state that 

it is the responsibility of the interested