69160 Federal Register / Vol. 70, No. 218 / Monday, November 14, 2005 / Notices 

V. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES), written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one 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. 

Dated: June 21, 2005. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. 05–22610 Filed 11–10–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2003D–0554] 

Revised Compliance Policy Guide 

Regarding Prior Notice of Imported 

Food Under the Public Health Security 

and Bioterrorism Preparedness and 

Response Act of 2002; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a revised compliance 

policy guide (CPG) Sec. 110.310 entitled 

‘‘Prior Notice of Imported Food Under 

the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002.’’ The CPG 

provides written guidance to FDA’s and 

Customs and Border Protection’s (CBP’s) 

staff on enforcement of section 307 of 

the Public Health Security and 

Bioterrorism Preparedness and 

Response Act of 2002 (the Bioterrorism 

Act) and the agency’s implementing 

regulations, which require prior notice 

for food imported or offered for import 

into the United States. The CPG has 

been revised to finalize the sections 

pertaining to routine shipments of food 

that are transshipped through the 

United States, arriving from and exiting 

to the same country, and regarding the 

Harmonized Tariff Schedule (HTS) code 

that is part of the planned shipment 

information. 

DATES: The revised CPG is final upon 

the date of publication. However, you 

may submit written or electronic 

comments on the revised CPG at any 

time. 

ADDRESSES: You may submit comments, 

identified by Docket No. 2003D–0544 

and/ Regulatory Information Number 

(RIN) number (if a RIN number has been 

assigned), by any of the following 

methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• Agency Web site: http:// 

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal or the 

agency Web site, as described in the 

Electronic Submissions portion of this 

paragraph. 

Instructions: All submissions received 

must include the agency name and 

Docket No(s). and RIN (if a RIN number 

has been assigned) for this rulemaking. 

All comments received may be posted 

without change to http://www.fda.gov/ 

ohrms/dockets/default.htm, including 

any personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm and insert the docket 

number(s), found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

Submit written requests for single 

copies of the revised guidance to the 

Division of Compliance Policy (HFC–

230), Office of Enforcement, Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857. Send one 

self-addressed adhesive label to assist 

that office in processing your request or 

include a fax number to which the 

guidance may be sent. 

FOR FURTHER INFORMATION CONTACT: 

Laura Draski, Office of Regulatory 

Affairs (HFC–180), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 866–521–2297. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of March 4, 

2005 (70 FR 10657), FDA announced the 

availability of a draft revision to CPG 

Sec. 110.310 entitled ‘‘Prior Notice of 

Imported Food Under the Public Health 

Security and Bioterrorism Preparedness 

and Response Act of 2002.’’ This revised 

guidance was issued with CBP 

concurrence and explains to FDA and 

CBP staff the new FDA and CBP policies 

on enforcement of section 307 of the 

Bioterrorism Act and its implementing 

regulations, which require prior notice 

to FDA of all food imported or offered 

for import into the United States (21 

CFR parts 1.276 through 1.285). The 

new policies provide additional 

flexibility in filing prior notice when, 

due to the geography, the only practical 

transportation route available for the 

shipment is through the United States 

and when there is a prior notice 

violation because the prior notice does 

not include the 6-digit HTS code for the 

article of food. 

FDA received 8 comments on the 

draft sections of the revised CPG. FDA 

reviewed and evaluated these comments 

and has modified the CPG with CBP 

concurrence, where appropriate. 

FDA is issuing this CPG as level 1 

guidance consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The CPG represents the 

agency’s current thinking on its 

enforcement policy concerning prior 

notice. It does not create or confer any 

rights for or on any person and does not 

operate to bind FDA or the public. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on the guidance document. 

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 revised 

CPG and received comments may be 

seen in the Division of Dockets 

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

Monday through Friday. 

Federal Register / Vol. 70, No. 218 / Monday, November 14, 2005 / Notices 69161 

III. Electronic Access 

An electronic version of the revised 

CPG is available on the Internet at 

http://www.fda.gov/ora under 

‘‘Compliance References.’’

Dated: November 4, 2005. 

Steve Niedelman, 

Acting Associate Commissioner for 

Regulatory Affairs. 

[FR Doc. 05–22500 Filed 11–10–05; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Public Health Services; Notice of 

Listing of Members of the Substance 

Abuse and Mental Health Services 

Administration’s Senior Executive 

Service Performance Review Board 

(PRB) 

The Substance Abuse and Mental 

Health Services Administration 

(SAMHSA) announces the persons who 

will serve on the Substance Abuse and 

Mental Health Services 

Administration’s Performance Review 

Board. This action is being taken in 

accordance with Title 5, U.S.C., Section 

4314(c)(4), which requires that members 

of performance review boards be 

appointed in a manner to ensure 

consistency, stability, and objectivity in 

performance appraisals, and requires 

that notice of the appointment of an 

individual to serve as a member be 

published in the Federal Register. 

The following persons will serve on 

the SAMHSA Performance Review 

Board, which oversees the evaluation of 

performance appraisals of SAMHSA’s 

Senior Executive Service (SES) 

members: 

Andrew C. Knapp, Chairperson, 

Eric Broderick, 

Curt Coy, 

Daryl W. Kade. 

For further information about the 

SAMHSA Performance Review Board, 

contact the Division of Management 

Systems, Substance Abuse and Mental 

Health Services Administration, 1 

Choke Cherry Road, Room 3–1017, 

Rockville, Maryland 20857, telephone 

(240) 276–1124 (not a toll-free number). 

Dated: November 8, 2005. 

Charles G. Curier, 

Administrator, SAMHSA. 

[FR Doc. 05–22538 Filed 11–10–05; 8:45 am] 

BILLING CODE 4160–01–M 

DEPARTMENT OF HOUSING AND 

URBAN DEVELOPMENT 

[Docket No. FR–4971–N–58] 

Notice of Submission of Proposed 

Information Collection to OMB; 

Procedures for Appealing Section 8 

Rent Adjustments 

AGENCY: Office of the Chief Information 

Officer, HUD. 

ACTION: Notice. 

SUMMARY: The proposed information 

collection requirement described below 

has been submitted to the Office of 

Management and Budget (OMB) for 

review, as required by the Paperwork 

Reduction Act. The Department is 

soliciting public comments on the 

subject proposal. 

When a rent increase for certain 

Section 8 subsidized projects is denied, 

in full or in part, owners may submit to 

HUD an appeal letter outlining the basis 

for the appeal. The appeal letter must be 

submitted to the Contract Administrator 

or the HUD Director for review. HUD 

uses the information to determine 

whether to deny or allow Section 8 rent 

increases. 

DATES: Comments Due Date: December 

14, 2005. 

ADDRESSES: Interested persons are 

invited to submit comments regarding 

this proposal. Comments should refer to 

the proposal by name and/or OMB 

approval Number (2502–0446) and 

should be sent to: HUD Desk Officer, 

Office of Management and Budget, New 

Executive Office Building, Washington, 

DC 20503; fax: 202–395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Wayne Eddins, Reports Management 

Officer, AYO, Department of Housing 

and Urban Development, 451 Seventh 

Street, SW., Washington, DC 20410; email Wayne_Eddins@HUD.gov; or 

Lillian Deitzer at 

Lillian_L_Deitzer@HUD.gov or 

telephone (202) 708–2374. This is not a 

toll-free number. Copies of available 

documents submitted to OMB may be 

obtained from Mr. Eddins or Ms. 

Deitzer. 

SUPPLEMENTARY INFORMATION: This 

notice informs the public that the 

Department of Housing and Urban 

Development has submitted to OMB a 

request for approval of the information 

collection described below. This notice 

is soliciting comments from members of 

the public and affected agencies 

concerning the proposed collection of 

information to: (1) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the functions of the agency, including 

whether the information will have 

practical utility; (2) Evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information; (3) Enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) Minimize the 

burden of the collection of information 

on those who are to respond; including 

through the use of appropriate 

automated collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 

This Notice Also Lists the Following 

Information 

Title of Proposal: Procedures for 

Appealing Section 8 Rent Adjustments. 

OMB Approval Number: 2502–0446. 

Form Numbers: None. 

Description of the Need for the 

Information and Its Proposed Use: 

When a rent increase for certain Section 

8 subsidized projects is denied, in full 

or in part, owners may submit to HUD 

an appeal letter outlining the basis for 

the appeal. The appeal letter must be 

submitted to the Contract Administrator 

or the HUD Director for review HUD 

uses the information to determine 

whether to deny or allow Section 8 rent 

increases. 

Frequency of Submission: On 

occasion. 

Number of 

respondents 

Annual 

responses × Hours per response = Burden hours 

Reporting burden ....................................................................................................... 500 1 2 1,000