Federal Register / Vol. 73, No. 1 / Wednesday, January 2, 2008 / Notices 191 

Status: The meeting will be closed to the 

public in accordance with provisions set 

forth in section 552b(c)(4) and (6), Title 5 

U.S.C., and the Determination of the Director, 

Management Analysis and Services Office, 

CDC, pursuant to Public Law 92–463. 

Matters To Be Discussed: The meeting will 

include the review, discussion, and 

evaluation of ‘‘National Institute for 

Occupational Safety and Health (NIOSH): 

Occupational Safety and Health Training 

Project Grants, PA PAR06–484.’’

Contact Person for More Information: 

Charles N. Rafferty, PhD, Assistant Director 

for Review and Policy, Office of Extramural 

Programs, Office of Extramural Coordination 

and Special Projects, NIOSH, CDC, 1600 

Clifton Road, NE., Mailstop E74, Atlanta, GA 

30333 Telephone: (404) 498–2530. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: December 21, 2007. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. E7–25544 Filed 12–31–07; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Mine Safety and Health Research 

Advisory Committee (MSHRAC): 

Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the following meeting of the 

aforementioned committee: 

Time and Date: 

8:45 a.m.—5:15 p.m., January 22, 2008. 

8:30 a.m.—3:45 p.m., January 23, 2008. 

Place: Hilton Garden Inn Pittsburgh/ 

Southpointe, 1000 Corporate Drive, 

Canonsburg, PA 15317, telephone (724) 743–

5000, fax (724) 743–5010. 

Status: The meeting room accommodates 

approximately 50 people. 

Purpose: This committee is charged with 

providing advice to the Secretary, 

Department of Health and Human Services; 

the Director, CDC; and the Director, NIOSH, 

on priorities in mine safety and health 

research, including grants and contracts for 

such research, 30 U.S.C. 812(b)(2), Section 

102(b)(2). 

Matters To Be Discussed: The meeting will 

focus on Communications and Tracking, 

update on Refuge Alternatives Activities, 

Mine Ground Control Research, Dynamic 

Failures Proposal, NAS Review and Planned 

Actions, Safety Culture Pilot Project and Coal 

Workers Pneumoconiosis Research. The 

agenda will also include an update report 

from the Associate Director for Mining. 

Agenda items are subject to change as 

priorities dictate. 

Contact Person for More Information: 

Jeffery L. Kohler, Ph.D., Executive Secretary, 

MSHRAC, NIOSH, CDC, 626 Cochrans Mill 

Road, Pittsburgh, PA 15236, telephone (412) 

386–5301, fax (412) 386–5300. The Director, 

Management Analysis and Services Office, 

has been delegated the authority to sign 

Federal Register notices pertaining to 

announcements of meetings and other 

committee management activities for both the 

Centers for Disease Control and Prevention 

and the Agency for Toxic Substances and 

Disease Registry. 

Dated: December 21, 2007. 

Elaine Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention (CDC). 

[FR Doc. E7–25509 Filed 12–31–07; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Center for Food Safety and Applied 

Nutrition; Statement of Organization, 

Functions, and Delegations of 

Authority 

Part D, Food and Drug 

Administration, Chapter DB, Office of 

Operations, Center for Food Safety and 

Applied Nutrition (DBF), 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 56005, November 9, 

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

pertinent part at 57 FR 54239) is 

amended to reflect the restructuring of 

the Center for Food Safety and Applied 

Nutrition (CFSAN), Office of Operations 

(OO), Food and Drug Administration 

(FDA) as follows: 

I. Under Chapter DB, Office of 

Operations, delete in its entirety, the 

‘‘Center for Food Safety and Applied 

Nutrition (DBF). 

II. Establish a new Chapter DH, Center 

for Food Safety and Applied Nutrition 

(DH), under Part D to read as follows: 

DF.10 Organization. The Center for 

Food Safety and Applied Nutrition, 

FDA is headed by the Director, Food 

Safety and Applied Nutrition, and 

includes the following organizational 

units: 

Office of the Center Director (DHA) 

Office of Management Systems (DHB) 

Office of Food Defense, Communication 

and Emergency Response (DHC) 

Office of Food Safety (DHD) 

Office of Cosmetics and Colors (DHE) 

Office of Regulatory Science (DHF) 

Office of Food Additive Safety (DHG) 

Office of Compliance (DHH) 

Office of Applied Research and Safety 

Assessment (DHI) 

Office of Regulations, Policy and Social 

Sciences (DHJ) 

Office of Nutrition, Labeling, and 

Dietary Supplements (DHK) 

DF.20 Functions. 

A. OFFICE OF THE CENTER 

DIRECTOR (DHA). The Office of the 

Center Director (OCD): 

Provides leadership and direction for 

all Center activities and coordinates 

programs with other Agency, 

Department and government agencies. 

Plans, administers, coordinates, 

evaluates and promulgates overall 

Center scientific, regulatory, 

compliance, enforcement and 

management programs, policies and 

plans. 

Provides leadership and direction for 

Center management, planning, and 

evaluation systems to ensure optimum 

utilization of personnel, financial 

resources, and facilities. 

Establishes and manages a program to 

maintain the highest level of quality and 

integrity for all Center laboratory studies 

and the processing of regulatory 

samples, and ensures that all Center 

laboratory studies subject to FDA’s 

Good Laboratory Practice regulations are 

conducted in compliance with them. 

Coordinates and monitors the Center’s 

overall research portfolio, including all 

research-related activities and inquiries 

and the development of strategic 

research program plans. 

B. SENIOR SCIENCE ADVISOR 

STAFF (DHA1). The Senior Science 

Advisor Staff (SSAS): 

Provides advice to the Center Director 

and Deputy Directors on issues related 

to the Center’s research portfolio, 

facilities and equipment. 

Represents the Center and Agency in 

scientific and other professional forums, 

including international forums, on 

issues related to food laws, regulations, 

standards and science and policies. 

Provides leadership for the 

development of short-, medium- and 

long-term strategic research program 

plans. 

Provides advice, consultation, and 

management oversight to appropriate 

representatives associated with 

partnerships with academia and other 

consortia. 

Fosters partnerships and effective 

communication with academia, private 

industry, trade associations, public 

sector groups, governmental agencies, 

commodity groups, and professional 

organizations. 


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192 Federal Register / Vol. 73, No. 1 / Wednesday, January 2, 2008 / Notices 

C. INTERNATIONAL AFFAIRS 

STAFF (DHA2). The International 

Affairs Staff (IAS): 

Provides advice to the Center Director 

and Deputy Directors on issues related 

to international policy and direction. 

Provides leadership on development 

of the Center’s policies that impact on 

international and/or trade issues. 

Represents the Center and Agency in 

international forums on issues related to 

international harmonization of food 

laws, regulations, standards and 

science, and policies. 

Provides expertise and oversight over 

international trade negotiations 

pertaining to foods and cosmetics and 

the implementation of the agreements 

that emerge from those negotiations, 

including management of any trade 

disputes. 

Coordinates activities between the 

Center and other Federal agencies, 

foreign competent authorities, and 

relevant stakeholders on issues having 

international components. 

Coordinates international technical 

assistance and training programs. 

D. EXECUTIVE OPERATIONS STAFF 

(DHA3). The Executive Operations Staff 

(EOS): 

Provides support to the Center 

Director and Deputy Directors, 

including the coordination and 

preparation of briefing materials and 

background information for meetings, 

responses to outside inquiries, and 

maintenance and control of the Center 

Director’s working files. 

Manages the Center’s Freedom of 

Information Act activities, coordinating 

responses with other Center technical, 

regulatory, and policy units as well as 

developing direct responses. Provides 

correspondence control for the Center 

and controls and processes all agency 

public correspondence directed to the 

Center Director. Develops and operates 

tracking systems designed to identify 

and resolve early warnings and 

bottleneck problems with executive 

correspondence. 

Coordinates the Center’s 

communications with the Agency, 

Department, and the other federal 

government agencies. 

Manages all Congressional activities 

including hearings, briefings, and 

inquiries (except for legislation). 

Acts as the focal point for all activities 

with respect to the Government 

Accountability Office (GAO) and the 

Office of the Inspector General. 

E. OFFICE OF MANAGEMENT 

SYSTEMS (DHB). The Office of 

Management Systems (OMS): 

Advises the Center Director on 

administrative policies and guidelines 

and scientific and technical information 

systems. 

Plans and directs all Center 

operations related to program planning, 

budget, financial, and security 

management, and laboratory safety and 

health. 

Performs management studies and 

evaluations, as necessary, throughout 

the Center. 

Provides technical support and 

building operations support 

management to the Center in the areas 

of supply, equipment, space, 

communications, printing, 

reproduction, mail, contracts and grants, 

and awards. 

Represents the Center’s information 

technology (IT) needs to Shared 

Services and the Chief Information 

Officer (CIO). Provides support to 

critical in-house data systems. 

F. OFFICE OF FOOD DEFENSE, 

COMMUNICATION AND EMERGENCY 

REPONSE (DHC). The Office of Food 

Defense, Communication and 

Emergency Response (OFDCER): 

Provides Center leadership for food 

defense and counterterrorism activities 

in relation to that segment of the U.S. 

food supply that is regulated by the 

Food and Drug Administration (FDA). 

Serves as FDA’s lead for directing, 

developing, and coordinating high 

quality outreach and education 

activities (in collaboration with Center 

Program offices) and as a resource to all 

stakeholders (e.g., consumers, industry, 

states, and other Federal partners) in 

relation to food safety, food labeling, 

and food defense. 

Leads the Center in coordinating, 

directing, and assisting other agency 

units with foodborne outbreak 

investigations and coordination of other 

emergency activities involving food, 

dietary supplements, and cosmetics. 

Provides direction for strengthening 

systems for conduct and coordination of 

risk analysis activities and related 

research associated with national and 

international food safety and food 

defense issues. 

Assists the Center’s Chief Medical 

Officer (CMO) as an expert for the 

Center in public health medicine, 

including Human Subject Protection 

(HSP) and Health Hazard Evaluations 

(HHE’s). 

Provides statistical and 

epidemiological support for Center and 

field research, extramural and 

regulatory programs. 

G. OFFICE OF FOOD SAFETY (DHD). 

The Office of Food Safety (OFS): 

Develops and implements policies, 

regulations, and guidelines related to 

food safety. Conducts food safety 

research related to chemical or 

microbial contamination. 

Administers the federal portion of the 

Federal/State cooperative programs. 

Provides toxicological evaluations and 

quantitative risk assessments related to 

the presence of industrial chemicals, 

process induced toxicants and toxic 

elements in food. 

Serves as the principal Agency liaison 

on food programs and policies with 

industry, Federal, State, foreign, and 

other organizations. 

Provides expertise in acidified and 

low acid food technologies, including 

the registration and evaluation of filed 

processes. 

Maintains the Interstate Certified 

Shellfish Shippers List and the 

Interstate Milk Shippers List. 

Serves as Agency liaison with State 

partners in administering the Federal 

portion of the federal/state cooperative 

retail food program. 

Develops and promotes the adoption 

and implementation of the FDA Food 

Code, the National Retail Food 

Regulatory Program Standards and 

related agency policy for sound public 

health practices. 

Provides technical support and 

outreach to FDA staff and other Federal, 

State and local officials on the Food 

Code and other agency guidance on 

retail food protection. 

H. OFFICE OF COSMETICS AND 

COLORS (DHE). The Office of Cosmetics 

and Colors (OCAC): 

Develops guidelines, regulations, and 

policies for cosmetics and color 

additives. Communicates policy, 

guidance, and other information on 

cosmetics and color additives to the 

public, affected industry, and other 

stakeholders including international 

regulatory bodies. 

Provides expert scientific and 

technical advice and support on 

cosmetic products and ingredients and 

color additives to other FDA units and 

other Federal, State, and local 

authorities. 

Administers the Color Certification 

program, including laboratory testing 

and methods research. 

Administers the Voluntary Cosmetic 

Registration Program. 

Provides leadership and works closely 

with other Agency units in the area of 

nanotechnology. 

I. OFFICE OF REGULATORY 

SCIENCE (DHF). The Office of 

Regulatory Science (ORS): 

Conducts laboratory science and 

research that support the FDA 

regulatory agenda. 

Develops laboratory-based methods to 

support regulations and related policy 

developments. 


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Federal Register / Vol. 73, No. 1 / Wednesday, January 2, 2008 / Notices 193 

Provides technical support and expert 

advice on scientific issues related to 

policy and regulations. 

Originates, plans, and conducts 

research in the areas of food processing 

and packaging, food chemistry, food 

toxicants, food microbiology and 

cosmetics. 

Reviews regulatory actions for 

adequacy of evidence and accuracy of 

the science and technical procedures 

and findings. 

Provides technical information and 

assistance with laboratory-based 

methods and procedures to foreign 

governments and visitors. 

J. OFFICE OF FOOD ADDITIVE 

SAFETY (DHG). The Office of Food 

Additive Safety (OFAS): 

Serves as the Center focal point for 

scientific and policy support for the 

development of Agency-initiated 

regulations on matters pertaining to the 

provisions of the food and color 

additive sections of the Federal Food, 

Drug, and Cosmetic Act. 

Manages the Center’s petition review 

processes (both those conducted inhouse and under extramural contract) 

for food and color additives, and 

consultation/notification processes for 

GRAS (Generally Recognized As Safe) 

substances, food contact substances, and 

foods and food ingredients derived from 

recombinant DNA biotechnology. 

Evaluates safety information, compiles 

the administrative record supporting 

actions on petitions and other agency 

actions, and prepares Federal Register 

documents relating to petitions. 

Prepares and/or reviews 

documentation required by the Center to 

implement the National Environmental 

Policy Act (NEPA). Coordinates the 

Center review of documents prepared 

under NEPA by other Federal agencies. 

Serves as the principal Agency liaison 

on safety testing methodologies and 

protocol standards needed to evaluate 

the safety of food ingredients and on 

other aspects of regulatory decisions. 

Develops compliance policy, position 

papers, procedural regulations, 

regulatory guidelines, and advisory 

opinions on issues related to the safe 

uses of food additives, food contact 

substances, color additives, GRAS 

substances, biotechnology derived 

foods, and prior sanctioned substances. 

Responds to stakeholder inquiries and 

processes Freedom of Information 

requests in a timely and efficient 

manner. Consults with Center and other 

FDA laboratories regarding research 

relevant to the regulation of food and 

color additives and food ingredients. 

Manages the Agency’s review and 

monitoring of identity, probable human 

exposure to, and toxicity information on 

food and color additives, food contact 

substances, and GRAS substances in 

current use. Recommends enforcement 

action or regulatory change as needed. 

Provides expert scientific and technical 

advice to other Office, Center, and 

Agency components as needed. 

Provides evaluation and participates 

in bioresearch monitoring of nonclinical laboratory studies and facilities 

to assure quality and integrity of data 

submitted to the Agency in accordance 

with good laboratory practices 

K. OFFICE OF COMPLIANCE (DHH). 

The Office of Compliance (OC): 

Serves as the primary contact between 

the Center and FDA’s field organization, 

including the Field Food Committee. 

Has primary responsibility for 

management of compliance programs, 

field assignments, and work plans and 

maintains the center-wide compliance 

management and reference systems. 

Initiates and/or coordinates the 

planning, development, publication and 

promotion of field guidance documents 

for CFSAN-regulated food and cosmetic 

products to implement sound public 

health practices, food safety/security 

interventions, compliance/enforcement 

strategies, and regulatory programs; 

provides information, training and 

technical assistance to implement 

development of Center guidance and 

regulations. 

Reviews proposed regulatory actions 

and recalls for adequacy of evidence 

and consistency across programs. 

Oversees the development of 

compliance and enforcement strategies 

for emerging compliance challenges. 

Monitors and mines information from 

internal and external sources to identify 

trends or emerging compliance and 

enforcement-related issues that may 

influence the Center’s area of regulatory 

responsibility. Provides data and other 

information on field accomplishments 

to support the Center’s evaluation of 

programs and assignments, 

development of new assignments, 

assessment of the industry or any other 

relevant Agency purpose. 

Oversees, monitors and evaluates the 

food facility registration data base. 

Plans and develops approaches to 

administer regulatory responsibilities in 

the Interstate Travel Program and 

provides information, problem-solving 

and technical assistance to Agency and 

external organizations within this 

program. 

L. OFFICE OF APPLIED RESEARCH 

AND SAFETY ASSESSMENT (DHI). 

The Office of Applied Research and 

Safety Assessment (OARSA): 

Establishes and conducts a cohesive 

mission-relevant research program in 

the areas of toxicology, microbiology 

and molecular biology that will ensure 

the safety of the U.S. food supply and 

the establishment of sound 

counterterrorism measures. 

Provides Center and Agency 

leadership in reproductive toxicology, 

neuro/behavioral toxicology, 

immunotoxicology, in vitro toxicology 

with special emphasis on 

hepatotoxicity, virulence assessment, 

immunobiology, microbial genetics and 

molecular virology. 

Recommends, develops, and conducts 

the Center’s research program goals and 

priorities on food safety threat agents, 

safety and health hazards to foods, 

nutritional supplements, chemical 

contaminants, natural toxicants, and 

metabolities. 

Serves as the Center’s principal 

research liaison with other Agency units 

and with other organizations outside the 

Agency. Initiates and coordinates 

collaborative studies with Center 

stakeholders and coordinates 

development of long-term collaborative 

research planning with the Center, other 

Agency units, academic, and research 

components to achieve food safety and 

food defense. 

Provides support to the national 

toxicological program with planning 

and implementation of sub-chronic and 

chronic toxicological evaluations 

emphasizing dose response 

relationships. Provides expert scientific 

direction, guidance and support to the 

Center’s regulatory and compliance 

programs and provides expertise in both 

food safety and food defense. 

M. OFFICE OF REGULATIONS, 

POLICY, AND SOCIAL SCIENCES 

(DHJ). Office of Regulations, Policy, and 

Social Sciences (ORPSS): 

Coordinates the development of all 

CFSAN regulations and guidance 

documents, and reviews and clears for 

CFSAN draft regulations and guidance 

documents developed by CFSAN, other 

Centers in FDA, or by other agencies. 

Resolves policy issues involving 

Center-regulated food or cosmetic 

products in collaboration with the 

Center Director, Deputy Directors and 

other senior managers. 

Provides economic analyses and 

conducts consumer studies to provide 

information about the impact and/or 

effectiveness of various options; these 

analyses and studies are used by CFSAN 

managers throughout the decisionmaking and evaluation processes. 

Serves as the Center focal point and 

provides a centralized monitoring, 

coordinating, and advisory function for 

the Center and U.S. government on 

policies involving sensitive, 

controversial, and complex food issues, 


pwalker on PROD1PC71 with NOTICES
194 Federal Register / Vol. 73, No. 1 / Wednesday, January 2, 2008 / Notices 

including policies involving food 

derived from biotechnology. 

Advises Center officials on regulatory 

approaches and manages the 

development of periodic plans for the 

Center’s regulation development 

activities. 

Develops legislative proposals related 

to food and cosmetic safety and defense; 

coordinates the Center’s review of bills 

and proposed legislation, upon request; 

and coordinates the Center’s technical 

assistance to Congressional or FDA 

Office of Legislation staff developing 

bills related to food and cosmetics, upon 

request. 

Manages the Center’s compliance 

with the Information Quality Act, 

including responses to request for 

correction and reconsideration 

submitted under the Act. 

Advises Center staff concerning the 

administrative procedures for 

rulemaking, guidelines, guidance 

documents, and other policy 

documents, hearings and delegations of 

authority. 

Leads the Center’s evaluation of 

existing regulations to determine 

whether they are efficiently or 

effectively accomplishing their intended 

purpose. 

Provides Center-level leadership and 

coordination regarding briefings with 

other parts of the Agency or Federal 

Government with clearance 

responsibility regarding CFSAN 

regulations and guidance documents, 

and other CFSAN documents subject to 

the Paperwork Reduction Act, in 

coordination with the Executive 

Operations Staff. 

Directs and manages Center programs 

involving the use of external scientific 

advisors, consultants, and committees. 

Counsels and coordinates with Center 

managers on the use of external 

scientific experts and resources. 

N. OFFICE OF NUTRITION, 

LABELING, AND DIETARY 

SUPPLEMENTS (DHK). The Office of 

Nutrition, Labeling, and Dietary 

Supplements (ONLDS): 

Primary responsibility for policy 

development and management of food 

and nutrition labeling, food standards, 

conventional foods, dietary 

supplements, and special nutritional 

(including infant formula and medical 

foods) food. 

Provides expert advice to the Center 

Director, other Deputy Directors, and 

other senior managers, and directs major 

Agency and Department nutrition and 

labeling initiatives and is the Delegate to 

national and international forums and 

conferences. 

Primary responsibility for policy and 

regulatory development and 

management of the food labeling 

program, including Nutrition Labeling 

and Education Act, Food Allergen 

Labeling and Consumer Protection Act 

and other Federal Food, Drug, and 

Cosmetic Act and Fair Packaging and 

Labeling Act labeling requirements. 

Provides scientific and technical 

review of and response to petitions and 

notifications related to all aspects of 

conventional food labeling. With the 

Office of Compliance, determines 

compliance with existing food standards 

and common or usual name regulations 

and issues temporary marketing permits 

to allow manufacturers to test market 

new foods. In addition, conducts 

scientific and technical review of 

enforcement and compliance materials 

including inspection reports, analytical 

reports and other pertinent records, and 

provides policy decisions on 

misbranding charges for all domestic 

and import actions, including infant 

formula and medical food 

manufacturers. 

Provides expert guidance for other 

Agency units and Federal and State 

officials and industry concerning 

regulatory requirements and compliance 

policies on food labeling (including 

infant formula and medical foods) and 

reviews proposed enforcement/ 

compliance actions referred by other 

agency units. 

Provides expert technical advice for 

participation in international forums. 

Reviews food product labeling 

(including infant formula, medical foods 

and nutrition labels) for adherence to 

regulations and appropriateness of 

claims and manages the Small Business 

Nutrition Labeling Exemption 

Notification Program. 

Provides scientific review and 

analysis of policies, regulations, 

research priorities, position papers, and 

advisory opinions on issues related to 

nutrition and nutrition labeling, and 

dietary guidance recommendations, and 

related nutrition science issues. 

Responsible for scientific and 

regulatory review of health claim 

petitions, qualified health claim 

petitions, nutrient content claim 

petitions, and FDA Modernization Act 

notifications for health claims and 

nutrient content claims. 

Provides expert advice and assistance 

to key officials and coordinates with 

other domestic and international 

scientific bodies on efforts related to 

nutrition and health. 

Identifies program priorities for, 

provides content design input to, and 

analysis of large-scale databases of food 

consumption, food composition, food 

ingredients, sales of processed packaged 

food products and product label 

information. Develops methods for 

monitoring US populations and special 

subgroups relative to use and safety of 

conventional foods and dietary 

supplements. 

Provides management and scientific 

review on issues related to infant 

formula, medical foods, and dietary 

supplements including petitions and 

notifications, and provides advice to key 

Agency components as well as 

international bodies. 

Responsible for the development of 

regulations, guidance, policy, programs, 

position papers and advisory opinions, 

and recommends research priorities for 

the management of the dietary 

supplement program, which includes 

safety assessments for the New Dietary 

Ingredient Notification Program, 

structure-function notifications, 

Certificates of Export, safety assessment 

for dietary supplement policy, 

responses to petitions and industryrelated notifications, post-market 

adverse event evaluations, and issues 

related to dietary supplement safety and 

nutrition. 

III. Delegations of Authority. Pending 

further delegation, directives, or orders 

by the Commissioner of the Food and 

Drugs, all delegations or re-delegations 

of authority to positions of the affected 

organizations in effect prior to this date 

shall continue in effect in them or their 

successors. 

Dated: December 20, 2007. 

Michael O. Leavitt, 

Secretary. 

[FR Doc. 07–6257 Filed 12–31–07; 8:45 am] 

BILLING CODE 4160–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0492] 

Guidance for Industry and Food and 

Drug Administration; Interactive 

Review for Medical Device 

Submissions: 510(k)s, Original PMAs, 

PMA Supplements, Original BLAs, and 

BLA Supplements; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the guidance entitled 

‘‘Interactive Review for Medical Device 

Submissions: 510(k)s, Original PMAs, 

PMA Supplements, Original BLAs, and 

BLA Supplements.’’ The purpose of this 

guidance document is to recommend an 


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