46022 Federal Register / Vol. 73, No. 153 / Thursday, August 7, 2008 / Notices 

1FDA has verified the Web site address, but FDA 

is not responsible for any subsequent changes to the 

Web site after this document publishes in the 

Federal Register. 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ohrms/ 

dockets/ac/acmenu.htm, click on the 

year 2008 and scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before August 27, 2008. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. Those desiring to make 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before August 19, 2008. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by August 20, 2008. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Kalyani 

Bhatt (301) 827–7001 at least 7 days in 

advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/oc/advisory/ 

default.htm for procedures on public 

conduct during advisory committee 

meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: July 29, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–18131 Filed 8–6–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0416] 

Consideration of FDA-Regulated 

Products That May Contain Nanoscale 

Materials; Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting and a request for 

comments including available data to 

gather information that will assist the 

agency in further implementing the 

recommendations of the 

Nanotechnology Task Force Report (the 

Report) relating to the development of 

agency guidances. The Report’s 

recommendations covered foods 

(including dietary supplements), food 

and color additives (including food 

contact substances), animal drugs and 

feeds, cosmetics, human drugs and 

biologics, and medical devices. In 

addition to requesting comments in 

response to the questions in this notice 

and those that will be discussed at the 

public meeting, FDA is announcing a 

request for available data and 

information on the effects of nanoscale 

materials on quality, safety, and, where 

relevant, effectiveness of products 

subject to FDA oversight. 

DATES: The public meeting will be held 

on September 8, 2008, from 8:30 a.m. to 

5 p.m. Anyone who wishes to speak at 

the meeting must register and submit a 

summary of the presentation and an 

electronic copy of the presentation by 

Tuesday, September 2, 2008. See section 

IV of the SUPPLEMENTARY INFORMATION

section of this document for details on 

how to register. Submit written or 

electronic comments by Friday, October 

24, 2008. 

ADDRESSES: The public meeting will be 

held at the University Systems of 

Maryland Shady Grove Center/ 

Universities, 9630 Gudelsky Dr., 

Rockville, MD 20850 (http:// 

www.shadygrove.umd.edu/conference).1

There is parking near the building. 

Submit written comments, available 

data, and other information to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Submit electronic comments 

to http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Megan Clark, Office of Policy, Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

3360, e-mail: megan.clark@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Nanotechnology allows scientists to 

work on the scale of molecules to create, 

explore, and manipulate materials 

measured in nanometers; billionths of a 

meter. In July 2007, FDA issued the 

Report analyzing scientific and 

regulatory considerations relating to the 

safety and effectiveness of FDAregulated products containing nanoscale 

materials regulated by FDA, and making 

recommendations regarding these 

considerations. Additionally, the Report 

summarized the state of the science for 

biological interactions with nanoscale 

materials. The Report also 

recommended that FDA coordinate with 

other Federal agencies and the private 

sector in research and other activities to 

increase general scientific 

understanding and facilitate assessment 

of data needs for regulated products. 

This coordination includes developing 

an infrastructure to share and leverage 

knowledge and build upon information 

from individual studies of nanoscale 

materials. 

The agency has been considering 

development of guidances 

recommended in the Report and 

believes that holding a public meeting 

and announcing this request for 

comments and available data will 

provide information that will assist in 

this task. In addition, FDA is working 

with the National Institutes of Health 

(particularly the NanoHealth Enterprise) 

to explore methods for receiving and 

sharing data relating to, for example, 

general product development, including 

research on failed product candidates, 

and biological interactions of certain 

characteristics of nanoscale materials. 

Such a data repository could allow FDA 

and other stakeholders to share data and 

methods, and to develop models of 

biological interaction that could then 

inform product development and 

review. 

II. Meeting Agenda 

The primary purpose of the meeting is 

to determine what factors the agency 

should consider in providing guidance 

on: 

1. The information and data that may 

be needed to demonstrate the safety and 

effectiveness of FDA-regulated products 

containing nanoscale materials and 


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Federal Register / Vol. 73, No. 153 / Thursday, August 7, 2008 / Notices 46023 

2. The circumstances under which a 

product’s regulatory status might change 

due to the presence or use of nanoscale 

materials (for example, making a device 

no longer exempt from 510(k) 

submission requirements). 

The meeting will begin with a plenary 

session at which FDA will review the 

goals of the meeting and give a general 

overview of the analysis and findings of 

the Nanotechnology Task Force and 

agency activities since publication of 

the Report in July 2007. The plenary 

session will frame topics that apply 

generally to all FDA-regulated products. 

Immediately following the plenary 

session, FDA will hold breakout 

sessions that will be structured to allow 

brief presentations by those who have 

submitted requests to speak in 

accordance with the instructions in this 

document. We encourage those speaking 

to provide detailed comments, 

information, and available data to the 

docket, and use time at the meeting to 

give a general overview of the submitted 

comments to facilitate discussion during 

the product-specific sessions. There will 

be a brief period set aside during these 

sessions to allow attendees who did not 

register to speak an opportunity to offer 

comments. These breakout sessions will 

be organized around the following 

product categories identified in the 

Report for which the agency has been 

considering the need for guidance: 

• Medical devices, including 

diagnostics (combination products may 

also be discussed in this session); 

• Prescription drugs, including 

biological drugs, animal drugs and overthe-counter (OTC) drugs, including 

sunscreens; 

• Food and color additives, including 

food contact substances; 

• Dietary supplements; and 

• Cosmetics. 

These sessions will generally cover 

the following questions: 

1. What characteristics of nanoscale 

materials in FDA-regulated products 

should be identified and evaluated to 

ensure the safety and, where relevant, 

effectiveness of these products? 

2. What assessment tools are available 

(including test methods and standards) 

for evaluating the characteristics of 

nanoscale materials that may affect the 

safety, effectiveness, and quality of 

FDA-regulated products? 

• How reliable are these tools? 

• How widely available are these 

tools? 

• Are these tools practical for 

regulatory use or do they have aspects 

that render them impractical? 

• What additional tools should FDA 

and industry consider developing to 

evaluate the characteristics of nanoscale 

materials? 

3. Are there unique features of the 

manufacturing process for products 

containing nanoscale materials? If so, 

how should these features be evaluated? 

• Is the manufacturing process for 

nanoscale materials different from that 

of conventional materials? If so, how? 

• What parameters are critical when 

manufacturing products containing 

nanoscale materials? 

• What unique challenges are there 

for ‘‘scale-up’’ of manufacturing for 

products using nanoscale materials? 

• How do potentially unique features 

of nanoscale materials, such as particle 

size, shape, and surface charge, affect 

what should be considered in the 

development of controls, standards, and 

specifications for manufacturing? 

4. Are there particular aspects of 

product formulation, processing, or 

storage that can affect the quality, safety, 

or effectiveness of products containing 

nanoscale materials, including as 

excipients? 

5. What has been your experience 

with products containing nanoscale 

materials? Have you avoided these 

products due to specific concerns about 

aspects of development, 

characterization, or manufacturing? 

6. What additional questions focusing 

on characterization (including stability) 

and manufacturing aspects of products 

containing nanoscale materials should 

be addressed in this forum or otherwise 

brought to the attention of FDA? 

The agency may develop additional 

questions for discussion during the 

breakout sessions and if so, they will be 

posted on the agency’s Web site at 

http://www.FDA.gov by Monday, 

August 11, 2008, and posted to the FDA 

Docket No. FDA–2008–N–0416. 

In addition to providing comments 

and information in response to the 

questions in this document and 

otherwise discussed at the public 

meeting, FDA is requesting that 

interested stakeholders submit 

comments which include available data 

and information on topics identified in 

the Report. We are requesting any 

available data that: 

• Identify OTC drug products that 

contain or may contain nanoscale 

versions of ingredients included in an 

OTC monograph; 

• Identify nanoscale versions of 

previously approved food and color 

additives; 

• Address the effects of nanoscale 

materials on the safety and, where 

relevant, effectiveness of FDA-regulated 

products, including both existing 

products that are changed to contain (or 

contain greater proportions of) 

nanoscale materials and new products 

made with nanoscale materials; 

• Address the effects that nanoscale 

versions of larger sized materials have 

on bioavailability; and 

• Address whether and how the 

presence of nanoscale materials affects 

the manufacturing processes for the 

various types of FDA-regulated 

products, including both products that 

require premarket authorization and 

those products that do not. 

Reporting Formats 

We are not requesting a specific 

format or reporting structure for 

comments which include such available 

data. However, we prefer data in 

electronic form where possible, in order 

to facilitate access and to reduce paper 

use. We are asking for available data 

related to specific products and, 

therefore, request that any submitted 

data be identified as pertaining to a 

particular product or category of 

products. We also request that you 

identify your data submission as being 

a comment in response to this 

document, and refer to the docket 

number found in brackets in the 

heading of this document. See section 

IV. COMMENTS, on how to submit 

comments. 

III. Meeting Registration, Agenda, and 

Transcript 

Seating will be available on a firstcome, first-served basis. If you need 

special accommodations because of a 

disability, please inform Megan Clark 

(see FOR FURTHER INFORMATION CONTACT) 

at least 7 days in advance. 

Registration for Speaking Attendees: 

If you wish to make an oral presentation 

at the meeting, you must register and 

submit a summary of your presentation 

to Megan Clark by Tuesday, September 

2, 2008, via e-mail to 

megan.clark@fda.hhs.gov. When 

registering, you must provide the 

following information: (1) The productspecific breakout session at which you 

wish to present; (2) the specific topic or 

issue to be addressed; (3) your name, 

title, company or organization, address, 

phone number, and e-mail address; and 

(4) the approximate, desired duration of 

your presentation. FDA encourages 

persons and groups having similar 

interests to consolidate their 

information for presentation through a 

single representative. After reviewing 

the requests to present, we will contact 

each participant with the amount of 

time available and the approximate time 

the participant’s presentation is 

scheduled to begin. Presenters must 

send electronic copies of their 

presentations in Microsoft PowerPoint, 


sroberts on PROD1PC70 with NOTICES
46024 Federal Register / Vol. 73, No. 153 / Thursday, August 7, 2008 / Notices 

Microsoft Word, or Adobe Portable 

Document Format (PDF) to Megan Clark 

at megan.clark@fda.hhs.gov by Tuesday, 

September 2, 2008. 

Meeting Agenda and Transcript: The 

agenda for the public meeting will be 

available on FDA’s Web site at http:// 

www.fda.gov/nanotechnology2008. 

After the meeting, the agenda, 

presentations, and transcript will be 

placed on file in the Division of Dockets 

Management under the docket number 

found in the heading of this document 

and on FDA’s Web site. 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http://www.fda.gov/ohrms/ 

dockets/ac/acmenu.htm. It may be 

viewed at the Division of Dockets 

Managment (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD. A transcript will 

also be available in either hardcopy or 

on CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information (HFI–35), Office 

of Management Programs, Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 6–30, Rockville, MD 20857. 

IV. Comments 

Regardless of attendance at the 

meeting, interested persons may submit 

to the Division of Dockets Management 

(see ADDRESSES) written or electronic 

comments related to the questions and 

the focus of this public meeting, as well 

as comments including available data 

and information submitted in response 

to the data call. All relevant data and 

information should be submitted with 

the written comments. 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 

posted without change to http:// 

www.regulations.gov, including any 

personal information provided. 

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 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Dated: July 31, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–18132 Filed 8–6–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Center for Substance Abuse 

Treatment; Notice of Meetings 

Pursuant to Public Law 92–463, 

notice is hereby given that the 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) 

Center for Substance Abuse Treatment 

(CSAT) National Advisory Council will 

meet on August 21, 2008, from 1 p.m. 

to 3 p.m. and on September 9, 2008, 

from 1:30 p.m. to 2:30 p.m. via 

teleconferences. 

The meetings will include discussion 

and evaluation of grant applications 

reviewed by Initial Review Groups. 

Therefore, the meetings will be closed to 

the public as determined by the 

Administrator, SAMHSA, in accordance 

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

U.S.C. App. 2, Section 10(d). 

Substantive program information, a 

summary of the meetings and a roster of 

Council members may be obtained as 

soon as possible after each meeting, 

either by accessing the SAMHSA 

Committee Web site at http:// 

www.nac.samhsa.gov, or by contacting 

CSAT National Advisory Council’s 

Designated Federal Official, Ms. Cynthia 

Graham (see contact information below). 

Committee Name: SAMHSA Center 

for Substance Abuse Treatment National 

Advisory Council. 

Dates/Times/Types: August 21, 2008, 

from 1 p.m. to 3 p.m.: CLOSED. 

September 9, 2008, from 1:30 p.m. to 

2:30 p.m.: CLOSED. 

Place: SAMHSA Building, 1 Choke 

Cherry Road, Great Falls Room, 

Rockville, Maryland 20857. 

Contact: Cynthia Graham, M.S., 

Designated Federal Official, SAMHSA 

CSAT National Advisory Council, 1 

Choke Cherry Road, Room 5–1035, 

Rockville, Maryland 20857, Telephone: 

(240) 276–1692, Fax: (240) 276–1690, 

e-mail: 

cynthia.graham@samhsa.hhs.gov. 

Toian Vaughn, 

Committee Management Officer, Substance 

Abuse and Mental Health Services 

Administration. 

[FR Doc. E8–18130 Filed 8–6–08; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[USCG–2008–0244] 

Collection of Information Under 

Review by Office of Management and 

Budget: OMB Control Numbers: 1625–

0081 and 1625–0083 

AGENCY: Coast Guard, DHS. 

ACTION: Thirty-day notice requesting 

comments. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, this 

request for comments announces that 

the U.S. Coast Guard is forwarding two 

Information Collection Requests (ICRs), 

abstracted below, to the Office of 

Information and Regulatory Affairs 

(OIRA), Office of Management and 

Budget (OMB) requesting an extension 

of their approval for the following 

collections of information: (1) 1625–

0081, Alternate Compliance Program, 

and (2) 1625–0083, Operational 

Measures for Existing Tank Vessels 

Without Double Hulls. Our ICRs 

describe the information we seek to 

collect from the public. Review and 

comments by OIRA ensure we only 

impose paperwork burdens 

commensurate with our performance of 

duties. 

DATES: Please submit comments on or 

before September 8, 2008. 

ADDRESSES: You may submit comments 

identified by Coast Guard docket 

number [USCG–2008–0244] to the 

Docket Management Facility (DMF) at 

the U.S. Department of Transportation 

(DOT) or to OIRA. To avoid duplication, 

please submit your comments by only 

one of the following means: 

(1) Electronic submission. (a) To Coast 

Guard docket at http:// 

www.regulations.gov. (b) To OIRA by email via: oira_submission@omb.eop.gov. 

(2) Mail or Hand delivery. (a) DMF 

(M–30), DOT, West Building Ground 

Floor, Room W12–140, 1200 New Jersey 

Avenue, SE., Washington, DC 20590–

0001. Hand deliver between the hours of 

9 a.m. and 5 p.m., Monday through 

Friday, except Federal holidays. The 

telephone number is 202–366–9329. (b) 

To OIRA, 725 17th Street, NW., 

Washington, DC 20503, to the attention 

of the Desk Officer for the Coast Guard. 

(3) Fax. (a) To DMF, 202–493–2251. 

(b) To OIRA at 202–395–6566. To 

ensure your comments are received in 

time, mark the fax to the attention of the 

Desk Officer for the Coast Guard. 

The DMF maintains the public docket 

for this Notice. Comments and material 


sroberts on PROD1PC70 with NOTICES