51306 Federal Register / Vol. 73, No. 170 / Tuesday, September 2, 2008 / Notices 

development or approval, of a drug 

product, and conduct otherwise relating 

to the regulation of a drug product 

under the act. 

As a result of the foregoing finding, 

Dr. Maria Anne Kirkman Campbell is 

permanently debarred from providing 

services in any capacity to a person with 

an approved or pending drug product 

application under sections 505, 512, or 

802 of the act (21 U.S.C. 355, 360b, or 

382), or under section 351 of the Public 

Health Service Act (42 U.S.C. 262), 

effective as stated in the DATES section 

of this document (see section 

306(c)(1)(B) and (c)(2)(A)(ii) and 201(dd) 

of the act (21 U.S.C. 321(dd))). Any 

person with an approved or pending 

drug product application who 

knowingly uses the services of Dr. 

Campbell in any capacity, during her 

period of debarment, will be subject to 

civil money penalties (section 307(a)(6) 

of the act (21 U.S.C. 335b(a)(6))). If Dr. 

Campbell, during her period of 

debarment, provides services in any 

capacity to a person with an approved 

or pending drug product application, 

she will be subject to civil money 

penalties (section 307(a)(7) of the act). 

In addition, FDA will not accept or 

review any abbreviated new drug 

application submitted by or with the 

assistance of Dr. Campbell during her 

period of debarment (section 

306(c)(1)(B) of the act). 

Any application by Dr. Campbell for 

special termination of debarment under 

section 306(d)(4) of the act should be 

identified with Docket No. FDA–2006–

N–0166 and sent to the Division of 

Dockets Management (see ADDRESSES). 

All such submissions are to be filed in 

four copies. The public availability of 

information in these submissions is 

governed by 21 CFR 10.20(j). Publicly 

available submissions may be seen in 

the Division of Dockets Management 

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

through Friday. 

Dated: August 22, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–20295 Filed 8–29–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0455] 

Guide to Minimize Microbial Food 

Safety Hazards for Fresh Fruits and 

Vegetables; Request for Comments 

and for Scientific Data and Information 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments 

and for scientific data and information. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

comments and scientific data and 

information that may assist the agency 

to improve the guidance to industry set 

forth in the ‘‘Guide to Minimize 

Microbial Food Safety Hazards for Fresh 

Fruits and Vegetables,’’ issued in 1998. 

Specifically, FDA is seeking information 

about current agricultural practices and 

conditions used to grow, harvest, pack, 

cool, and transport fresh produce; risk 

factors for contamination of fresh 

produce associated with these practices; 

and possible measures that FDA could 

implement that would enhance the 

safety of fresh produce. 

DATES: Submit written comments and 

scientific data and information or 

electronic comments by December 31, 

2008. 

ADDRESSES: Submit written comments 

and scientific data and information to 

the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments and scientific data 

and information to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to this document. 

FOR FURTHER INFORMATION CONTACT: 

Michelle A. Smith, Center for Food 

Safety and Applied Nutrition (HFS–

317), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740–3835, 301–436–2024. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Food Safety and Fresh Produce 

FDA is responsible for ensuring the 

safety of all domestic and imported 

fresh fruits and vegetables consumed in 

the United States. Fresh fruits and 

vegetables are those that are likely to be 

sold to consumers in an unprocessed or 

minimally processed (i.e., raw) form. 

Fresh fruits and vegetables may be 

intact and whole, such as whole apples, 

or cut in the act of harvest, such as 

heads of lettuce and bunches of 

broccoli. 

Because most fresh produce is grown 

in a natural environment, it is 

vulnerable to contamination with 

pathogens (i.e., bacteria or other 

organisms that can cause disease). 

Factors that may affect the occurrence of 

such contamination include agricultural 

and/or post-harvest water quality, the 

use of manure as fertilizer, the presence 

of wild or domestic animals in or near 

fields or packing areas, worker health 

and hygiene, environmental conditions, 

production activities, and equipment 

and facility sanitation. Consequently, 

the manner in which fresh produce is 

grown, harvested, packed, cooled, and 

transported is crucial to minimizing the 

risk of microbial contamination. (We 

use the term ‘‘microbial contamination’’

to refer to contamination with any 

microorganism.) 

Data reported to the U.S. Centers for 

Disease Control and Prevention (CDC) 

indicate that between 1973 and 1997 

reported outbreaks of foodborne illness 

in the United States associated with 

fresh produce increased in absolute 

numbers and as a proportion of all 

reported foodborne outbreaks (Ref. 1). 

(By ‘‘outbreak,’’ we mean the occurrence 

of two or more cases of a similar illness 

resulting from the ingestion of a 

common food.) Unpublished data 

compiled by FDA indicate that from 

1996 to 2007 there were approximately 

72 reported outbreaks of foodborne 

illness associated with approximately 

20 fresh produce commodities. Of this 

total, 13 outbreaks were associated with 

tomatoes, 11 outbreaks were associated 

with melons, and 24 outbreaks were 

associated with leafy greens such as 

lettuce and spinach (Ref. 2). These 

outbreaks involved a number of 

pathogens, including Escherichia coli 

(E. coli) O157:H7 and Salmonella 

species, and involved both domestic 

and imported produce. These totals 

include only those outbreaks in which 

our investigation has indicated that the 

contamination of the produce was not a 

result of exposure to an infected food 

handler or other unsafe food handling 

practice at the place of preparation and 

consumption (i.e., home or restaurant). 

There have also been a number of 

reported outbreaks associated with fresh 

produce in 2008. 

B. FDA’s GAPs/GMPs Guide 

FDA places a high priority on 

identifying and promoting measures 

that can reduce the incidence of 

foodborne illness associated with fresh 

produce. In 1998, FDA and the U.S. 

Department of Agriculture issued 


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guidance to industry entitled ‘‘Guide to 

Minimize Microbial Food Safety 

Hazards for Fresh Fruits and 

Vegetables’’ (Ref. 3), to enhance the 

safety of fresh produce, to assist the 

fresh produce industry in addressing 

common risk factors in their operations, 

and to minimize potential food safety 

hazards. (The document is referred to 

hereinafter as the ‘‘GAPs/GMPs 

Guide’’—GAPs is an abbreviation of 

‘‘good agricultural practices’’ and GMPs 

is an abbreviation of ‘‘good 

manufacturing practices.’’) While FDA 

recognizes current technologies cannot 

eliminate all potential food safety 

hazards associated with fresh produce 

that will be eaten raw, the GAPs/GMPs 

Guide emphasizes that implementation 

of risk reduction measures is critical to 

minimizing these potential food safety 

hazards. The agency has worked with 

the fresh produce industry and other 

food safety partners since the issuance 

of the GAPs/ GMPs Guide to promote its 

recommendations and to advance the 

scientific knowledge applicable to 

enhancing the safety of fresh produce, 

and the GAPs/GMPs Guide has been 

used as a basis for a number of food 

safety programs, both in the United 

States and internationally. Choices by 

buyers to purchase from producers and 

other suppliers that provide self- or 

third-party audit verification that they 

are following the GAPs/GMPs Guide 

have further promoted adoption of the 

guidance. 

Subsequent to the issuance of the 

GAPs/GMPs Guide, FDA has 

undertaken a number of produce safety 

initiatives that have enhanced its 

understanding of the effectiveness of the 

GAPs/GMPs Guide in reducing the risk 

of produce-associated foodborne illness. 

Examples include the 2004 ‘‘Produce 

Safety From Production to 

Consumption: 2004 Action Plan to 

Minimize Foodborne Illness Associated 

with Fresh Produce Consumption,’’

commonly called the ‘‘Produce Safety 

Action Plan’’ (Ref. 4), which focuses on 

prevention of contamination, 

minimization of public health impacts 

when contamination does occur, 

communication with the public and 

stakeholders, and facilitation and 

support of research; the multi-year 

‘‘Leafy Greens Safety Initiative’’ (Ref. 5), 

launched in 2006 in collaboration with 

the State of California, which involves 

assessment of practices and conditions 

at select farms and facilities in 

California, including adoption and 

implementation of good agricultural 

practice and good manufacturing 

practice recommendations (for packing 

houses) and requirements (for fresh-cut 

processing facilities); and the 2007 

‘‘Tomato Safety Initiative’’ (Ref. 6), a 

multi-year collaboration similar to the 

‘‘Leafy Greens Safety Initiative’’ with 

the States of Virginia and Florida, as 

well as several universities and 

members of the produce industry. 

Available data and FDA’s experience 

suggest that the GAPs/GMPs Guide (and 

other public and private sector efforts) 

have accurately identified certain 

potential sources of microbial 

contamination of fresh produce, such as 

agricultural water and worker health 

and hygiene. Data and experience also 

indicate that the recommendations in 

the GAPs/GMPs Guide can be effective 

when implemented. However, the fact 

that outbreaks of foodborne illness 

associated with fresh produce continue 

to occur supports a close examination of 

the extent to which the 

recommendations in the GAPs/GMPs 

Guide have been implemented; the 

extent to which they have been 

effective, if implemented properly; and 

what additional or different 

interventions might be appropriate to 

reduce the risk of future outbreaks. The 

agency recognized when it issued the 

GAPs/GMPs Guide in 1998 that it would 

need to be updated ‘‘[a]s new 

information and technological advances 

expand the understanding of those 

factors associated with identifying and 

reducing microbial food safety hazards’’

(Ref. 3). In the 10 years since the GAPs/ 

GMPs Guide was released many changes 

have occurred in the produce industry, 

and a great deal of new knowledge and 

information have become available. In 

addition, the agency now has 10 years 

experience in implementing this 

guidance and observing how and the 

extent to which it has been 

implemented by the industry. 

In addition to the initiatives described 

previously, in 2007 FDA held two 

public hearings to inform stakeholders 

about produce-associated outbreaks and 

to solicit comments to inform the 

agency in determining the next steps 

(Ref. 7). In both instances, the agency 

asked a series of questions. Among these 

questions, we asked whether FDA’s 

current GAPs/GMPs Guide needs to be 

expanded or otherwise revised, and if 

the response was yes, we solicited 

comments about what areas need to be 

expanded or otherwise revised. 

Comments were generally in agreement 

that the basic principles set out in the 

1998 guidance remain sound. However, 

they were split on whether FDA should 

update the GAPs/GMPs Guide and, if so, 

how it might be revised. Several 

comments suggested the GAPs/GMPs 

Guide should provide more specific and 

directive recommendations. A number 

of comments suggested that the GAPs/ 

GMPs Guide needs more explicit 

information to facilitate risk assessment. 

Other comments urged FDA to keep the 

GAPs/GMPs Guide broad in scope, and 

to focus instead on education/outreach 

to promote adoption of existing 

recommendations. 

FDA has taken the comments received 

in response to the 2007 public hearings 

into consideration and incorporated 

relevant suggestions as it conducts the 

produce safety activities mentioned in 

this Federal Register document and 

other activities implementing the 

‘‘Produce Safety Action Plan.’’ However, 

because most comments did not provide 

substantive information or data in 

response to this question, FDA has 

determined that it would benefit from 

another, more focused opportunity for 

public comment. 

Thus, FDA is now soliciting 

comments and scientific data and 

information on any possible measures 

and technological advances that would 

assist the agency in improving the 

agency’s current GAPs/GMPs Guide. 

Specifically, FDA is seeking information 

and comment on the issues and 

questions in section II of this document. 

When possible, please provide scientific 

information and data in support of your 

comments. In addition, please provide 

information as specific as is feasible 

about the estimated costs and benefits 

associated with your responses (e.g., the 

costs and benefits of current practices 

and/or the cost and benefits of any 

recommendations you may make). FDA 

is not seeking information and comment 

on issues of traceability in this 

document, because FDA plans to do so 

in the context of a public meeting. 

II. Issues and Questions 

Issue 1: The GAPs/GMPs Guide 

addresses potential sources of microbial 

contamination associated with a range 

of issues, or variables, such as: Water 

(both agricultural water and post harvest 

water uses); manure and municipal biosolids; worker health and hygiene; 

packing facility sanitation; 

transportation; and traceback (Ref. 3). 

Data from our experience over the past 

decade support the inclusion of many of 

these issues as risk factors for produceassociated foodborne illness outbreaks. 

Some of these potential sources of 

contamination in particular, such as 

worker health and hygiene, water 

quality (pre- and post-harvest), domestic 

and wild animal issues, and facility and 

equipment sanitation have been cited 

frequently by investigators during 

inspections at farms and facilities that 

were implicated in outbreak 

investigations. On the other hand, 


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51308 Federal Register / Vol. 73, No. 170 / Tuesday, September 2, 2008 / Notices 

although there remains a significant 

potential for contamination, some issue 

areas, such as the intentional use of 

manure or bio-solids as an agricultural 

input, have not been cited as a potential 

source of contamination to the same 

extent. The current guidance does not 

attempt to rank the potential hazard 

variables in terms of relative risk or 

importance. 

Question 1. Should any future GAPs/ 

GMPs Guide rank or prioritize among 

potential issues according to relative 

risk or importance? If yes, please offer 

suggestions of how that information 

could most effectively be presented in a 

way that does not detract from the broad 

scope of the current guidance. 

Issue 2: The GAPs/GMPs Guide tends 

to be arranged by issue area, while more 

recent industry commodity specific 

supply chain guidelines are divided 

according to where the commodity is 

within the supply chain (e.g., 

production, packing, distribution) and/ 

or the chronological order of activities at 

each step. 

Question 2. How should the GAPs/ 

GMPs Guide be organized to enhance its 

usefulness? 

Question 3. While the GAPs/GMPs 

Guide has been generally accepted and 

widely adopted, we know that there are 

entities in the fresh produce industry 

that are not aware of it. What measures 

can be taken, and by whom, to expand 

awareness by the fresh produce industry 

of the GAPs/GMPs Guide? 

Question 4. How should the GAPs/ 

GMPs Guide be modified to motivate all 

operations to implement? Please include 

information on economic impact. 

Question 5. Can the GAPs/GMPs 

Guide be applied equally to, and 

implemented by, domestic and foreign 

growers and packers? If not, should the 

GAPs/GMPs Guide be revised to 

incorporate additional options or 

special considerations (e.g., utilizing 

draft animals for agricultural tasks) for 

application and implementation? Please 

explain. 

Question 6. Is there a need for 

additional guidance to assist an operator 

in determining which provisions of the 

Current Good Manufacturing Practice 

regulations in part 110 (21 CFR part 

110) (e.g., post-harvest water quality, 

disease control, cleanliness, and 

supervision) could be implemented 

voluntarily for operations that currently 

are excluded under § 110.19? If so, 

which ones? 

Issue 3: Written food safety plans, 

sanitation standard operating 

procedures (SSOPs), standard operating 

procedures (SOPs), and monitoring 

records serve as useful tools for both 

industry and regulators. Such records 

assist operators to conduct operations in 

a manner that enhances the safety of 

fresh produce. For growers, an 

assessment of factors such as the field 

environment and agricultural inputs 

contributes to the development of 

written food safety plans and SOPs, and 

also helps to determine which factors 

should be monitored and the frequency 

of such monitoring. (The use of the term 

‘‘assessment’’ refers to an evaluation 

conducted by, or on behalf of, a grower 

or operator to identify measures to 

enhance food safety.) 

Written food safety plans, SOPs, 

SSOPs, and monitoring records also 

assist regulators to verify consistent and 

long-term implementation of certain 

practices. On-site inspections, either 

alone or in conjunction with records 

review, are another approach to such 

verification. (The use of the term 

‘‘inspection’’ refers to an evaluation 

conducted by, or on behalf of, a 

regulator to evaluate whether operations 

comply with applicable guidance or 

regulations. The term ‘‘audit’’ refers to 

a self or third-party evaluation of 

whether operations are consistent with 

voluntary guidelines and written food 

safety plans or SSOPs developed by the 

grower, operator, or buyer.) 

Question 7. Should the GAPs/GMPs 

Guide recommend that growers and/or 

other relevant operations develop a 

written food safety plan, written SOPs, 

and/or written SSOPs? If so, please 

describe the types of information or 

recommendations that you believe 

would be helpful. 

Question 8. Records can be divided 

into the following two broad groups: (1) 

Records to facilitate traceback, and (2) 

non-traceback or operational records. 

Does the GAPs/GMPs Guide provide 

sufficient recommendations regarding 

record keeping? If not, please describe 

what would be most helpful and why, 

e.g., information about the record 

keeping regulation (21 CFR 1 subpart J), 

guidance on what makes a ‘‘good’’

record, guidance on periodic record 

review and verification, and required or 

recommended record retention times. 

What types of monitoring records or 

other documentation would be most 

useful to industry and regulators? 

Question 9. The recent produce safety 

initiatives concerning leafy greens and 

tomatoes (Refs. 5 and 6) have 

highlighted the importance of 

performing environmental assessments 

(e.g., assessing water source quality, 

water distribution systems, animal 

presence, and other risk factors that may 

be associated with the production 

environment) before planting, 

throughout production, and prior to 

harvest. Would it be useful to enhance 

coverage of these concepts in the GAPs/ 

GMPs Guide? If yes, please describe. 

Question 10. Several newer produce 

safety programs, such as the California 

Leafy Green Products Handler 

Marketing Agreement (Ref. 8), 

incorporate recommendations (or 

requirements) for microbial testing. 

Does the information on microbial 

testing in the GAPs/GMPs Guide 

provide sufficient information to assist 

operators in designing a meaningful and 

cost effective testing program? If not, 

please describe what types of additional 

information would be most useful, such 

as how and where microbial testing 

might best be used to achieve food 

safety objectives, e.g., building a history 

of agricultural water quality, making 

best management decisions, verifying 

food safety operations. 

Question 11. Some comments 

submitted in connection with the 2007 

public hearings expressed concerns that 

field management activities intended to 

minimize microbial hazards, such as 

removing vegetation to reduce animal 

harborage near the production field, 

could have a negative, albeit 

unintended, impact on the environment 

and water sheds, among other areas. 

What data support these concerns? 

Could/should the GAPs/GMPs Guide do 

more to identify, address, and possibly 

mitigate unintended environmental 

consequences of food safety measures? 

Question 12. Are there existing 

regulatory requirements at the Federal, 

State, or local level that act as a 

disincentive (or as an incentive) for 

growers or other operators to implement 

agricultural or manufacturing practices 

that should be taken into consideration 

when updating this guidance to reduce 

the risk of microbial contamination of 

fresh produce? If yes, please identify 

and explain. 

III. 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 paper 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. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 


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Federal Register / Vol. 73, No. 170 / Tuesday, September 2, 2008 / Notices 51309 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

IV. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

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

through Friday. (FDA has verified the 

Web site addresses, but FDA is not 

responsible for any subsequent changes 

to the Web sites after this document 

publishes in the Federal Register.) 

1. Sivapalasingam, S., et al. ‘‘Fresh 

Produce: A Growing Cause of Outbreaks of 

Foodborne Illness in the United States, 1973 

through 1997,’’ Journal of Food Protection 

67(10): 2342–53, 2004. 

2. U.S. Food and Drug Administration, 

1996 to 2007 Produce Outbreaks 

(unpublished compilation). 

3. U.S. Food and Drug Administration, 

‘‘Guide to Minimize Microbial Food Safety 

Hazards for Fresh Fruits and Vegetables,’’

October 26, 1998, available at http:// 

www.cfsan.fda.gov/~dms/prodguid.html. 

4. U.S. Food and Drug Administration, 

‘‘Produce Safety From Production to 

Consumption: 2004 Action Plan to Minimize 

Foodborne Illness Associated with Fresh 

Produce Consumption,’’ October 2004, 

available at http://www.cfsan.fda.gov/~dms/ 

prodpla2.html. 

5. U.S. Food and Drug Administration, 

‘‘Leafy Greens Safety Initiative—2nd year,’’

October 4, 2007, available at http:// 

www.cfsan.fda.gov/~dms/lettsaf2.html. 

6. U.S. Food and Drug Administration, 

‘‘Tomato Safety Initiative,’’ June 12, 2007, 

available at http://www.cfsan.fda.gov/~dms/ 

tomsafe.html. 

7. ‘‘Safety of Fresh Produce; Public 

Hearings; Request for Comments’’ (72 FR 

8750, February 27, 2007), Public hearings 

held on March 20, 2007, and April 13, 2007, 

http://www.regulations.gov/fdmspublic/ 

component/ 

main?main=DocketDetail&d=FDA–2007–N–

0380. 

8. California Leafy Green Products Handler 

Marketing Agreement, available at http:// 

www.caleafygreens.ca.gov. 

II. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.cfsan.fda.gov/~dms/ 

prodguid.html. 

Dated: August 19, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–20187 Filed 8–29–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0466] 

Over the Counter Cough and Cold 

Medication for Pediatric Use; Notice of 

Public Hearing; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearing; request 

for comments; correction. 

SUMMARY: The Food and Drug 

Administration is correcting a notice 

that published in the Federal Register 

on August 25, 2008 (73 FR 50033). The 

notice announced a public hearing to 

obtain input regarding over-the-counter 

(OTC) cough and cold drugs marketed 

for pediatric use. Due to some confusion 

regarding electronic registration, this 

notice revises the electronic registration 

procedures, and corrects the address for 

the contact person. 

DATES: The correction is effective 

September 2, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Faith Dugan, Food and Drug 

Administration, 10903 New Hampshire 

Ave., rm. 6182, Silver Spring, MD 

20993, 301–796–3446, 

Faith.Dugan@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

E8–19657, published on August 25, 

2008 (73 FR 50033), the following 

correction is made to ADDRESSES: 

1. On page 50033, in the first and 

second columns, the ADDRESSES section 

is corrected to read as follows: 

ADDRESSES: Submit written comments to 

the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, 

rm. 1061, Rockville, MD 20852. 

E-mail electronic registration to: 

Faith.Dugan@fda.hhs.gov. Anyone who 

has already registered via http:// 

www.regulations.gov does not have to 

re-register. The agency will accept those 

registrations. 

Submit electronic comments to http:// 

www.regulations.gov. All comments 

should be identified with the docket 

number found in brackets in the 

heading of this document. 

Transcripts of the hearing will be 

available for review at the Division of 

Dockets Management and on the 

Internet at http://www.regulations.gov 

approximately 30 days after the hearing. 

For Registration to Attend and/or 

Participate in the Hearing: Seating at the 

hearing is limited. People interested in 

attending should submit electronic 

registration to Faith Dugan by close of 

business on September 15, 2008. 

Registration is free and will be on a firstcome, first-served basis. Written or 

electronic comments will be accepted 

until December 2, 2008. 

If you wish to make an oral 

presentation at the hearing, you must 

state your intention on your registration 

submission (see ADDRESSES). To speak, 

submit your name, title, business 

affiliation, address, telephone and fax 

numbers, and e-mail address. FDA has 

included questions for comment in 

section II of this document. You should 

also identify by number each question 

you wish to address in your 

presentation. FDA will do its best to 

accommodate requests to speak. 

Individuals and organizations with 

common interests are urged to 

consolidate or coordinate their 

presentations, and to request time for a 

joint presentation. FDA will determine 

the amount of time allotted to each 

presenter and the approximate time that 

each oral presentation is scheduled to 

begin. 

If you need special accommodations 

because of a disability, please inform 

Faith Dugan, (see For Information on the 

Hearing Contact). 

For Information on the Hearing 

Contact: Faith Dugan, Food and Drug 

Administration, 10903 New Hampshire 

Ave., rm. 6182, Silver Spring, MD 20993 

, 301–796–3446, FAX: 301–847–4752, email: Faith.Dugan@fda.hhs.gov. 

Dated: August 27, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–20370 Filed 8–28–08; 11:15 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 


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