65904 Federal Register / Vol. 70, No. 210 / Tuesday, November 1, 2005 / Notices 

ANNUAL BURDEN ESTIMATES—Continued 

Instrument Number of respondents 

Number of responses per 

respondent 

Average burden hours per 

response 

Total burden 

hours 

Child Welfare Agency Workers ........................................................................ 120 1 2 240 

Total .......................................................................................................... ........................ ........................ ........................ 656 

Estimated Total Annual Burden 

Hours: 656. 

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: October 28, 2005. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 05–21674 Filed 10–31–05; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0426] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Notice of 

Participation 

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 

reporting requirements for filing a 

notice of participation with FDA. 

DATES: Submit written or electronic 

comments on the collection of 

information by January 3, 2006. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/ 

dockets/ecomments. 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 Management 

Programs (HFA-250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–4659. 

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 

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. 

Notice of Participation—21 CFR 12.45 

(OMB Control Number 0910–0191)— 

Extension 

Section 12.45 (21 CFR 12.45) issued 

under section 701 of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 371), 

sets forth the format and procedures for 

any interested person to file a petition 

to participate in a formal evidentiary 

hearing, either personally or through a 

representative. Section 12.45 requires 

that any person filing a notice of 

participation, state their specific interest 

in the proceedings, including the 

specific issues of fact about which the 

person desires to be heard. This section 

also requires that the notice include a 

statement that the person will present 

testimony at the hearing and will 

comply with specific requirements in 

§ 12.85. Or, in the case of a hearing 

before a Public Board of Inquiry (21 CFR 

13.25), concerning disclosure of data 

and information by participants. In 

accordance with § 12.45(e) the presiding 

officer may omit a participant’s 

appearance. 

The presiding officer and other 

participants will use the collected 

information in a hearing to identify 

specific interests to be presented. This 

preliminary information serves to 

expedite the prehearing conference and 

commits participation. 

The respondents are individuals or 

households, State or local governments, 

not for profit institutions, and 

Federal Register / Vol. 70, No. 210 / Tuesday, November 1, 2005 / Notices 65905 

businesses, or other for profit groups 

and institutions. 

FDA estimates the burden of this 

collection of information as follows: 

21 CFR Section No. of Respondents Annual Frequency 

per Response Total Annual Responses Hours per Response Total Hours 

12.45 264 1 264 3 792 

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

Dated: October 26, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–21774 Filed 10–31–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005D–0412] 

Guidance for Industry: A Notice from 

the Food and Drug Administration to 

Growers, Food Manufacturers, Food 

Warehouse Managers, and 

Transporters of Food Products on 

Decontamination of Transport 

Vehicles; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘A Notice from the Food and 

Drug Administration to Growers, Food 

Manufacturers, Food Warehouse 

Managers, and Transporters of Food 

Products on Decontamination of 

Transport Vehicles.’’ This guidance is 

intended to provide information and 

references that can be used for the 

decontamination of food transport 

vehicles following Hurricanes Katrina 

and Rita in August and September 2005. 

The scope of this guidance is limited to 

decontamination of trucks, rail cars, and 

cold storage units that were flooded or 

otherwise impacted by the hurricanes, 

before being placed back in service to 

transport or store food. 

DATES: This guidance is final upon the 

date of publication. Submit written or 

electronic comments on agency 

guidances at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Division of Plant Product Safety (HFS–

305), Center for Food Safety and 

Applied Nutrition, Food and Drug 

Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20747. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests or include a fax number to 

which the guidance may be sent. Submit 

written comments on the guidance to 

the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Michael E. Kashtock, Center for Food 

Safety and Applied Nutrition (HFS–

305), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20747, 301–436–2022. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the aftermath of Hurricanes Katrina 

and Rita, the Center for Food Safety and 

Applied Nutrition has received 

inquiries about how food transport units 

such as trucks, rail cars, and cold 

storage units that were flooded or 

otherwise impacted by the hurricanes 

may be decontaminated for return to 

service to transport food. FDA is 

announcing the availability of a 

guidance document that provides 

information and references addressing 

this subject. 

FDA is issuing this document as a 

level 1 guidance consistent with FDA’s 

good guidance practices regulation 

(§ 10.115 (21 CFR 10.115)). The 

guidance is being implemented 

immediately without prior public 

comment, under § 10.115(g)(2), because 

the agency has determined that prior 

public participation is not feasible or 

appropriate. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this guidance. 

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. The guidance 

and received comments may be seen in 

the Division of Dockets Management 

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

through Friday. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the guidance document at 

http://www.cfsan.fda.gov/ 

guidance.html. 

Dated: October 14, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–21642 Filed 10–31–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, call the 

HRSA Reports Clearance Officer on 

(301) 443–1129. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology.