50112 Federal Register / Vol. 72, No. 168 / Thursday, August 30, 2007 / Notices 

and small business knowledge in 

general. 

FOR FURTHER INFORMATION CONTACT: 

Aaron Collmann, Room 6029, GSA 

Building, 1800 F Street, NW., 

Washington, DC 20405 (202) 501–1021 

or email at sbac@gsa.gov. 

SUPPLEMENTARY INFORMATION: This 

notice is published in accordance with 

the provisions of the Federal Advisory 

Committee Act (FACA) (Pub. L. 92–

463). 

Dated: August 27, 2007 

Michael J. Rigas 

Deputy Associate Administrator,Office of 

Small Business Utilization,General Services 

Administration. 

[FR Doc. 07–4282 Filed 8–28–07; 12:35 pm] 

BILLING CODE 6820–34–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0041] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Administrative Procedures for the 

Clinical Laboratory Improvement 

Amendments of 1998 Categorization; 

Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register of May 16, 2007 (72 FR 27573). 

The document announced that a 

proposed collection of information had 

been submitted to the Office of 

Management and Budget (OMB) for 

review and clearance under the 

Paperwork Reduction Act of 1995. The 

document was published with an error. 

This document corrects that error. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

1472. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

E7–9435, appearing on page 27573 in 

the Federal Register of Wednesday, May 

16, 2007, the following correction is 

made: 

1. On page 27574, in the third 

column, in the third full paragraph, the 

sentence ‘‘The likely respondents for 

this collection are Investigational New 

Drug Application Sponsors.’’ is 

corrected to read ‘‘The likely 

respondents for this collection of 

information are manufacturers of 

medical devices.’’

Dated: August 23, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–17153 Filed 8–29–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Office of the Commissioner; Statement 

of Organizations, Functions, and 

Delegations of Authority 

Part D, Chapter D–B, (Food and Drug 

Administration), of the Statement of 

Organization, Functions, and 

Delegations of Authority for the 

Department of Health and Human 

Services (35 FR 3685, February 25, 

1970, and 60 FR 56605, November 9, 

1995, 64 FR 36361, July 6, 1999, and in 

pertinent part at 57 FR 54239) is being 

amended to reflect the restructuring of 

the Office of the Commissioner (OC), 

Food and Drug Administration (FDA). 

This reorganization includes the 

establishment of four Deputy-level 

offices within the Office of the 

Commissioner, the changes are as 

follows: 

I. Under Part D, Food and Drug 

Administration, delete the Office of the 

Commissioner (DA) in its entirety and 

replace with the following: 

DA.10 Organization. The Food and 

Drug Administration (FDA) is headed by 

the Commissioner, Food and Drug and 

includes the following organizational 

units: 

Office of the Commissioner (DA), 

Office of the Chief Counsel (DAA), 

Office of the Chief of Staff (DAB), Office 

of International and Special Programs 

(DAL), Office of Operations (DAM), 

Office of Policy, Planning and 

Preparedness (DAH), Office of Scientific 

and Medical Programs (DAE). 

DA.20 Functions 

A. Office of the Commissioner D(A)—

The Office of the Commissioner (OC) 

includes the Commissioner and Deputy 

Commissioner who are responsible for 

the efficient and effective 

implementation of FDA mission. 

B. Office of the Chief Counsel 

(DAA)—The Office of the Chief Counsel 

(OCC) is also known as the Food and 

Drug Division, Office of the General 

Counsel, Department of Health and 

Human Services), while 

administratively within the Office of the 

Commissioner, is part of the Office of 

the General Counsel of the Department 

of Health and Human Services. 

1. Is subject to the professional 

supervision and control of the General 

Counsel, Department of Health and 

Human Services (HHS), and represents 

FDA in court proceedings and 

administrative hearings with respect to 

programs administered by FDA. 

2. Provides legal advice and policy 

guidance for programs administered by 

FDA. 

3. Acts as liaison to the Department of 

Justice and other Federal agencies for 

programs administered by FDA. 

4. Drafts or reviews all proposed and 

final regulations and Federal Register 

notices prepared by FDA. 

5. Performs legal research and gives 

legal opinions on regulatory issues, 

actions, and petitions submitted to FDA. 

6. Reviews proposed legislation 

affecting FDA that originates in HHS or 

on which Congress requests the views of 

the Department. 

7. Provides legal advice and 

assistance to the Office of the Secretary 

on matters within the expertise of the 

Chief Counsel. 

C. Office of the Chief of Staff (DAB)—

The Office of the Chief of Staff (OCOS): 

1. Advises and provides integrated 

policy analysis and strategic 

consultation to the Commissioner, 

Deputy Commissioners, Associate 

Commissioners, Center Directors and 

other FDA officials on activities and 

issues that affect significant agency 

programs, projects and initiatives. Often 

this function involves the most difficult 

problems, crisis situations and 

extremely complex issues of FDA. 

2. Provides leadership, coordination 

and management of the Commissioner’s 

priority policies and issues across the 

Office of the Commissioner and FDAwide. Identifies, triages, supervises and 

tracks related actions from start to finish 

in conjunction with senior leadership 

across FDA. 

3. Provides ddidrect support to the 

Commissioner of Food and Drugs and 

serves as major point of contact between 

the FDA Centers and Offices and the 

Commissioner. 

4. Serves as the principal liaison to 

HHS and coordinates and manages 

activities between FDA and HHS. Works 

with the FDA Centers and Offices to 

ensure assignments or commitments 

made related to these activities are 

carried out. 

5. Serves as one of the 

Commissioner’s primary strategic 

liaisons with staff, partners, and the 

community at large. 

6. Manages budget and resources and 

provides operation oversight for the 

FDA’s Office of Legislation, Office of the 


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Executive Secretariat, Office of Public 

Affairs, and Office of External Relations 

7. Provides top level leadership and 

guidance on issues and actions tied to 

the FDA’s external communications, 

public affairs, and legislative matters. 

D. Office of International & Special 

Programs (DAL). The Office of 

International and Special Programs 

(OISP): 

1. Serves as FDA focal point for all 

international matters, pediatric matters, 

and combination product matters. 

2. Advises the Commissioner and 

other key FDA officials on FDA’s 

formulation and execution and cross 

cutting and precedent setting issues 

involving international, pediatric, and 

combination product matters. 

3. Serves as the agency liaison with 

other U.S. Government components, 

international and foreign governments 

(including Washington, DC embassies) 

for policy formulation and execution 

impacting FDA and FDA regulated 

products. 

4. Directs and monitors FDA strategic 

planning, priority-setting, and resource 

allocation processes for FDA 

international, pediatric and combination 

product matters. 

5. Provides leadership to FDA 

program areas for international, 

pediatric and combination product 

activities. 

6. Serves as the focal point for FDA 

international visitor program. 

7. Serves as the focal point for FDA 

and the authority for policies and 

procedures pertaining to international 

travel. 

8. Serves as the focal point for 

international-related training (external 

and internal). 

9. Serves as the focal point for FDA 

international technical cooperation and 

assistance activities. 

10. Serves as FDA focal point for all 

information exchange with foreign 

counterparts on international matters to 

ensure consistency internally and 

externally. 

11. Serves as FDA focal point for 

contacts with foreign governments and 

international organizations (including 

Washington, DC embassies). 

12. Serves as FDA focal point for 

planning and coordinating meetings 

involving international, pediatric and 

combination product matters. 

E. Office of Operations (DAM)—The 

office of Operations (00): 

1. Provides executive direction, 

leadership, coordination, and guidance 

for the overall day-to-day operations of 

FDA assuring the timely and effective 

implementation of operations and high 

quality delivery of services across FDA 

and its Centers. 

2. Oversees the day-to-day operational 

activities and the interaction and 

execution of new program initiatives 

across all Centers, Field offices, Regions, 

and the Office of the Commissioner. 

3. Advises and assists the 

Commissioner, Deputy Commissioners, 

Chief of Staff, Chief Counsel, Center 

Directors, and other key FDA officials 

on various management and business 

processes, compliance-oriented and 

legislative matters of FDA. 

4. Works with other senior FDA 

leadership to make decisions that are 

consistent with broad conceptual 

guidelines of the Commissioner, to meet 

the changing needs of FDA and new 

legislation. 

5. Leads FDA effort to analyze agency 

business processes for process 

modernization and bioinformatics 

support. 

6. Leads and coordinates the 

Prescription Drug User Fee Act program 

initiative for Performance Management 

and quality systems studies. 

7. Coordinates FDA’s business process 

planning function in support of 

business process improvement and 

automation efforts. 

8. Provides executive leadership and 

operational oversight to the Office of the 

Commissioner. 

9. Assure that the conduct of FDA 

administrative and financial 

management activities, including 

budget, finance, human resources, 

organization, methods, and similar 

support activities effectively support 

program operations. 

10. Provides FDA’s administrative 

management services including 

information technology, 

communications, financial transaction 

functions, procurement, facilities, and 

equal employment opportunity and 

diversity management. Utilizes a call 

center to address all administrative and 

information technology management 

issues, and monitors and analyzes 

operational performance and customer 

satisfaction. 

11. Plans, directs and coordinates a 

comprehensive financial management 

program for FDA encompassing the 

areas of automated financial systems, 

fiscal accounting, voucher audit, and 

financial reporting. Issues periodic 

reports regarding the status of FDA’s 

financial management and develops 

financial inputs for FDA’s programs and 

financial plans. 

12. Provides leadership and direction 

regarding all aspects of a variety of FDA 

management programs including 

internal controls, OIG liaison, 

organization management, delegations 

of authority, freedom of information, 

privacy act, and regulatory dockets 

management as well as programs related 

to ethics and conflict of interest matters. 

13. Advises the Commissioner and 

other key Agency officials on 

administrative management and budget 

matters for components within the 

Office of the Commissioner (OC). 

14. Provides advice and guidance 

with regard to formulation and 

development of administrative 

management policies; procedures, and 

controls. 

15. Provides advice and assistance to 

the Commissioner and senior 

management officials in information 

technology resources and programs. 

Establishes and oversees 

implementation of the FDA information 

technology policy and governance, 

procedures and processes to bring the 

Agency in conformance with the 

Clinger/Cohen Act. Establishes, directs 

and leads FDA level programs and all 

strategic aspects of information 

technology including: information 

technology (IT) shared services, 

telecommunications, security, strategic 

planning, capital planning and 

investment control, and enterprise 

architecture. 

16. Plans, organizes, and carries out 

annual and multi-year budgeting in 

support of FDA’s public health mission 

and programs. Provides staff assistance 

in justifying budgets through executive 

and congressional echelons. After 

appropriations, develops an orderly 

expenditure plan. 

17. Serves as the first responder for 

FDA in emergency and crisis situations 

involving FDA regulated products or in 

situations where FDA regulated 

products are needed to be utilized or 

deployed. 

F. Office of Policy, Planning and 

Preparedness (DAH)—The Office of 

Policy, Planning and Preparedness 

(OPPP): 

1. Advises the Commissioner and 

other key FDA officials on matters 

relating to policy, development of 

regulations and guidance, legislative 

issues, and planning and evaluation 

activities, and counter-terrorism and 

emerging threats. 

2. Participates with the Commissioner 

in the formulation of the basic policies 

and operational philosophy, which 

guide FDA in effectively implementing 

its responsibilities. 

3. Oversees and directs the FDA’s 

rulemaking activities and regulations 

and guidance development system. 

4. Serves as FDA focal point for 

developing and maintaining 

communications, policies, and programs 

with regard to development. 

5. Oversees and directs FDA planning 

and evaluation activities, including the 


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50114 Federal Register / Vol. 72, No. 168 / Thursday, August 30, 2007 / Notices 

development of programs and planning 

strategies through analysis and 

evaluation of issues affecting policies 

and program performance. 

G. Office of Scientific and Medical 

Programs (DAE). The Office of Scientific 

and Medical Program (OSMP): 

1. Serves as the focus for scientific 

medical and related activities in the 

Office of the Commissioner. 

2. Assists the Deputy Commissioner/ 

Chief Medical Officer in planning, 

executing and monitoring FDA 

scientific and medical projects and 

programs. 

3. Operates the following FDA 

programs: a. Orphan Drug Program; b. 

Women’s Health Program; c. Good 

Clinical Practices Program; d. Critical 

Path Initiative Program; and e. FDA 

Fellowship Program. 

4. Performs scientific research on the 

safety of regulated products through the 

National Center for Toxicological 

Research. 

5. Manages FDA’s committee on 

Research Involving Human Subjects and 

FDA’s Science Board. 

6. Represents the FDA on U.S. 

government committees and other 

Federal agencies on matters involving 

science or technology. 

7. Manages processes related to 

research coordination and scientific 

peer review activities at FDA. 

II. Delegations of Authority. Pending 

further delegation, directives or orders 

by the Commissioner of the Food and 

Drugs, all delegations and redelegations 

of authority made to officials and 

employees of affected organizational 

components will continue in them or 

their successors pending further 

redelegations, provided they are 

consistent with this reorganization. 

Dated: August 23, 2007. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. 07–4259 Filed 8–29–07; 8:45 am] 

BILLING CODE 4160–01–M 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[Docket No. CGD17–07–002] 

Cook Inlet Regional Citizen’s Advisory 

Committee; Charter Renewal 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of recertification. 

SUMMARY: The Coast Guard has 

recertified the Cook Inlet Regional 

Citizen’s Advisory Council for the 

period covering September 1, 2007, 

through August 31, 2008. Under the Oil 

Terminal and Oil Tanker Environmental 

Oversight Act of 1990, the Coast Guard 

may certify on an annual basis an 

alternative voluntary advisory group in 

lieu of a regional citizens’ advisory 

council for Cook Inlet, Alaska. This 

advisory group monitors the activities of 

terminal facilities and crude oil tankers 

under the Cook Inlet Program 

established by the statute. 

DATES: The Cook Inlet Regional Citizen’s 

Advisory Council is certified through 

August 31, 2008. 

ADDRESSES: You may request a copy of 

the recertification letter by writing to 

Commander, Seventeenth Coast Guard 

District (dpi), P.O. Box 25517, Juneau, 

AK 99802–5517; or by calling 907–463–

2809. 

FOR FURTHER INFORMATION CONTACT: 

Lieutenant Commander Gary Koehler, 

Seventeenth Coast Guard District (dpi), 

telephone 907–463–2809. 

SUPPLEMENTARY INFORMATION: 

Background and Purpose 

On September 1, 2006, the Coast 

Guard recertified the Cook Inlet 

Regional Citizen’s Advisory Council 

through August 31, 2007. Under the Oil 

Terminal and Oil Tanker Environmental 

Oversight Act of 1990 (33 U.S.C. 2732), 

the Coast Guard may certify, on an 

annual basis, an alternative voluntary 

advisory group in lieu of a regional 

citizens’ advisory council for Cook Inlet, 

Alaska. This advisory group monitors 

the activities of terminal facilities and 

crude oil tankers under the Cook Inlet 

Program established by Congress, 33 

U.S.C. 2732(b). 

On September 16, 2002, the Coast 

Guard published a notice of policy on 

revised recertification procedures for 

alternative voluntary advisory groups in 

lieu of councils at Cook Inlet, Alaska (67 

FR 58440, 58441). This revised policy 

indicated that Cook Inlet Regional 

Citizen’s Advisory Council 

recertification in 2006 need only submit 

a streamlined application and public 

comments would not be solicited prior 

to that recertification. 

Dated: August 13, 2007. 

Arthur E. Brooks, 

Rear Admiral, U.S. Coast Guard Commander, 

Seventeenth Coast Guard District. 

[FR Doc. E7–17145 Filed 8–29–07; 8:45 am] 

BILLING CODE 4910–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Immigration and Customs 

Enforcement 

Agency Information Collection 

Activities: Extension of an Existing 

Information Collection; Comment 

Request 

ACTION: 30-day notice of information 

collection under review; National 

Security Entry-Exit Registration System; 

OMB Control No. 1653–0036 

The Department of Homeland 

Security, U.S. Immigration and Customs 

Enforcement (USICE), has submitted the 

following information collection request 

for review and clearance in accordance 

with the Paperwork Reduction Act of 

1995. The information collection was 

previously published in the Federal 

Register on June 29, 2007, Vol. 72, No. 

125 35714, allowing for a 60-day 

comment period. No comments were 

received on this information collection. 

The purpose of this notice is to allow 

an additional 30 days for public 

comments. Comments are encouraged 

and will be accepted for thirty days 

until October 1, 2007. 

Written comments and suggestions 

regarding items contained in this notice, 

and especially with regard to the 

estimated public burden and associated 

response time should be directed to the 

Department of Homeland Security 

(DHS), Lee Shirkey, Program Manager, 

Records Management Branch, U.S. 

Immigration and Customs Enforcement, 

425 I Street, NW., Room 1122, 

Washington, DC 20536; (202) 353–2266. 

Written comments and suggestions 

from the public and affected agencies 

concerning the proposed collection of 

information should address one or more 

of the following four points: 

(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 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used, 

(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, 

electronic, mechanical, or other 

technological collection techniques or 


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