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 

69346 Federal Register / Vol. 70, No. 219 / Tuesday, November 15, 2005 / Notices 

organizations to confer with one another 

and to select a candidate, within 60 

days after the receipt of the FDA letter, 

to serve as the nonvoting member to 

represent industry interests for a 

particular committee. If no individual is 

selected within 60 days, the 

Commissioner of Food and Drugs will 

select the nonvoting member to 

represent industry interests. 

III. Application Procedure 

Individuals may self nominate and/or 

an organization may nominate one or 

more individuals to serve as a nonvoting 

industry representative. A current 

curriculum vitae and the name of the 

committee of interest should be sent to 

the FDA contact person. FDA will 

forward all nominations to the 

organizations expressing interest in 

participating in the selection process for 

that committee. (Persons who nominate 

themselves as nonvoting industry 

representatives will not participate in 

the selection process.) 

FDA has a special interest in ensuring 

that women, minority groups, 

individuals with physical disabilities, 

and small businesses are adequately 

represented on its advisory committees, 

and therefore, encourages nominations 

for appropriately qualified candidates 

from these groups. Specifically, in this 

document, nominations for nonvoting 

representatives of industry interests are 

encouraged from drug manufacturing 

industry. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: November 4, 2005. 

Jason Brodsky, 

Acting Associate Commissioner for External 

Relations. 

[FR Doc. 05–22562 Filed 11–14–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[USCG–2005–22878] 

Collection of Information Under 

Review by Office of Management and 

Budget (OMB): OMB Control Numbers: 

1625–0022, 1625–0079, 1625–0088, 

1625–0093, and 1625–0094. 

AGENCY: Coast Guard, DHS. 

ACTION: Request for comments. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, the 

U.S. Coast Guard intends to seek the 

approval of OMB for the renewal of five 

Information Collection Requests (ICRs). 

The ICRs are: (1) 1625–0022, 

Application for Tonnage Measurement 

of Vessels; (2) 1625–0079, Standards of 

Training, Certification and 

Watchkeeping for Seafarers (STCW), 

1995 and 1997 Amendments to the 

International Convention; (3)1625–0088, 

Voyage Planning for Tank Barge 

Transits in the Northeast United States; 

(4) 1625–0093, Facilities Transferring 

Oil or Hazardous Materials in Bulk—

Letter of Intent and Operations Manual; 

and (5) 1625–0094, Ships Carrying Bulk 

Hazardous Liquids. Before submitting 

the ICRs to OMB, the Coast Guard is 

inviting comments on them as described 

below. 

DATES: Comments must reach the Coast 

Guard on or before January 17, 2006. 

ADDRESSES: To make sure that your 

comments and related material do not 

enter the docket [USCG–2005–22878] 

more than once, please submit them by 

only one of the following means: 

(1) By mail to the Docket Management 

Facility, U.S. Department of 

Transportation (DOT), room PL–401, 

400 Seventh Street SW, Washington, DC 

20590–0001. 

(2) By delivery to room PL–401 on the 

Plaza level of the Nassif Building, 400 

Seventh Street SW, Washington, DC, 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

The telephone number is 202–366–

9329. 

(3) By fax to the Docket Management 

Facility at 202–493–2251. 

(4) Electronically through the Web 

Site for the Docket Management System 

at http://dms.dot.gov. 

The Docket Management Facility 

maintains the public docket for this 

notice. Comments and material received 

from the public, as well as documents 

mentioned in this notice as being 

available in the docket, will become part 

of this docket and will be available for 

inspection or copying at room PL–401 

on the Plaza level of the Nassif Building, 

400 Seventh Street SW., Washington, 

DC, between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

You may also find this docket on the 

Internet at http://dms.dot.gov. 

Copies of the complete ICRs are 

available through this docket on the 

Internet at http://dms.dot.gov, and also 

from Commandant (CG–611), U.S. Coast 

Guard Headquarters, room 6106 (Attn: 

Mr. Arthur Requina), 2100 Second 

Street SW., Washington, DC 20593–

0001. The telephone number is 202–

267–2326. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Arthur Requina, Office of Information 

Management, telephone 202–267–2326, 

or fax 202–267–4814, for questions on 

these documents; or telephone Ms. 

Renee V. Wright, Program Manager, 

Docket Operations, 202–493–0402, for 

questions on the docket. 

SUPPLEMENTARY INFORMATION: 

Public Participation and Request for 

Comments 

We encourage you to respond to this 

request for comments by submitting 

comments and related materials. We 

will post all comments received, 

without change, to http://dms.dot.gov; 

they will include any personal 

information you have provided. We 

have an agreement with DOT to use the 

Docket Management Facility. Please see 

the paragraph on DOT’s ‘‘Privacy Act 

Policy’’ below. 

Submitting comments: If you submit a 

comment, please include your name and 

address, identify the docket number 

[USCG–2005–22878], indicate the 

specific section of the document to 

which each comment applies, and give 

the reason for each comment. You may 

submit your comments and material by 

electronic means, mail, fax, or delivery 

to the Docket Management Facility at 

the address under ADDRESSES; but 

please submit them by only one means. 

If you submit them by mail or delivery, 

submit them in an unbound format, no 

larger than 81⁄2 by 11 inches, suitable for 

copying and electronic filing. If you 

submit them by mail and would like to 

know that they reached the Facility, 

please enclose a stamped, self-addressed 

postcard or envelope. We will consider 

all comments and material received 

during the comment period. We may 

change the documents supporting this 

collection of information or even the 

underlying requirements in view of 

them. 

Viewing comments and documents: 

To view comments, as well as 

documents mentioned in this notice as 

being available in the docket, go to 

http://dms.dot.gov at any time and 

conduct a simple search using the 

docket number. You may also visit the 

Docket Management Facility in room 

PL–401 on the Plaza level of the Nassif 

Building, 400 Seventh Street, SW., 

Washington, DC, between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. 

Privacy Act: Anyone can search the 

electronic form of all comments 

received in dockets by the name of the 

individual submitting the comment (or 

signing the comment, if submitted on 

behalf of an association, business, labor 

union, etc.). You may review the 

Privacy Act Statement of DOT in the 

Federal Register published on April 11,