56830 Federal Register / Vol. 73, No. 190 / Tuesday, September 30, 2008 / Notices 

Administration for Children and 

Families, 370 L’Enfant Promenade, SW., 

Washington, DC. The meeting will be 

open to the public; however, seating is 

limited and pre-registration is 

encouraged (see below). 

FOR FURTHER INFORMATION CONTACT: 

Roberta Lavin, Office of Human Services 

Emergency Preparedness and Response, 

e-mail roberta.lavin@acf.hhs.gov or 

(202) 401–9306. 

SUPPLEMENTARY INFORMATION: The 

National Commission on Children and 

Disasters (henceforth ‘‘the 

Commission’’) is a commission that 

shall independently conduct a 

comprehensive study to examine and 

assess the needs of children as they 

relate to preparation for, response to, 

and recovery from all hazards, building 

upon the evaluations of other entities 

and avoiding unnecessary duplication 

by reviewing the findings, conclusions, 

and recommendations of these entities. 

The Commission shall then submit a 

report to the President, the Secretary of 

Health and Human Services, and the 

Congress on the Commission’s 

independent and specific findings, 

conclusions, and recommendations to 

address the needs of children as they 

relate to preparation for, response to, 

and recovery from all hazards, including 

major disasters and emergencies. The 

Commission implements the intent of 

Congress as expressed in The 

Consolidated Appropriations Act, 2008 

(Pub. L. 110–161), Division G, Title VI, 

(henceforth ‘‘the Act’’) signed into law 

on December 26, 2007, authorizing 

funds for a body performing the 

functions here assigned to the 

Commission. 

The Commission will hear 

presentations on and discuss: (1) The 

Department of Health and Human 

Services’ efforts to support the needs of 

children in disaster situations; (2) the 

Federal Emergency Management 

Administration’s efforts to support the 

needs of children in disaster situations; 

(3) White House perspectives on the 

Administration’s efforts to support the 

needs of children in disaster situations; 

and (4) plans for future work of the 

Commission. 

The meeting will be open to the 

public; however, seating is limited and 

pre-registration is encouraged. To preregister, please e-mail 

carol.apelt@acf.hhs.gov with ‘‘Meeting 

Registration’’ in the subject line, or call 

Carol Apelt at (202) 205–4618 by 5 p.m. 

EST, October 9, 2008. Registration must 

include your name, affiliation, phone 

number. If you require a sign language 

interpreter or other special assistance, 

please call Carol Apelt at (202) 205– 

4618 as soon as possible and no later 

than October 6, 2008. 

Dated: September 24, 2008. 

Charles Keckler, 

Deputy Assistant Secretary for Policy for 

Children and Families. 

[FR Doc. E8–22939 Filed 9–29–08; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–N–0270] (formerly 

Docket No. 2007N–0357) 

Medical Device User Fee and 

Modernization Act; Notice to Public of 

Web Location of 2009 Proposed 

Guidance Development 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

Web location where the agency will post 

a list of guidance documents the Center 

for Devices and Radiological Health 

(CDRH) is considering for development 

in fiscal year (FY) 2009. In addition, 

FDA has established a docket where 

stakeholders may provide comments 

and/or draft language for those topics as 

well as suggestions for new or different 

guidances. 

DATES: Submit written or electronic 

comments at any time. 

ADDRESSES: Submit written comments 

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. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Deborah A. Wolf, Center for Devices and 

Radiological Health (HFZ–215), Food 

and Drug Administration, 1350 Piccard 

Dr., Rockville, MD 20850, 240–276– 

2350. 

SUPPLEMENTARY INFORMATION: 

I. Background 

During negotiations over the 

reauthorization of the Medical Device 

User Fee and Modernization Act 

(MDUFMA), FDA agreed, in return for 

additional funding from industry, to 

meet a variety of quantitative and 

qualitative goals intended to help get 

safe and effective medical devices to 

market more quickly. These 

commitments include annually posting 

a list of guidance documents that CDRH 

is considering for development and 

providing stakeholders an opportunity 

to provide comments and/or draft 

language for those topics, or suggestions 

for new or different guidances. This 

notice announces the Web location of 

the list of guidances (see § 10.115(c)(1) 

(21 CFR 10.115(c)(1))) on which CDRH 

is intending to work over the next FY. 

We note that the agency is not required 

to issue every guidance on the list, nor 

is it precluded from issuing guidance 

documents that are not on the list. The 

list includes topics that currently have 

no guidance associated with them, 

topics where updated guidance may be 

helpful, and topics for which CDRH has 

already issued level 1 drafts that may be 

finalized following review of public 

comments. We will consider 

stakeholder comments as we prioritize 

our guidance efforts. 

FDA and CDRH priorities are subject 

to change at any time. Topics on this 

and past guidance priority lists may be 

removed or modified based on current 

priorities. We also note that CDRH’s 

experience over the years has shown 

that there are many reasons CDRH staff 

does not complete the entire annual 

agenda of guidances it undertakes. Staff 

are frequently diverted from guidance 

development to other activities, 

including review of premarket 

submissions or postmarket problems. In 

addition, the Center is required each 

year to issue a number of guidances that 

it cannot anticipate at the time the 

annual list is generated. These may 

involve newly identified public health 

issues as well as special control 

guidance documents for de novo 

classifications of devices. It will be 

helpful, therefore, to receive comments 

that indicate the relative priority of 

different guidance topics to interested 

stakeholders. 

Through feedback from stakeholders, 

including draft language for guidance 

documents, CDRH expects to be able to 

better prioritize and more efficiently 

draft guidances that will be useful to 

industry and other stakeholders. This 

will be the second annual list CDRH has 

posted. FDA intends to update the list 

each year. 

FDA invites interested persons to 

submit comments on any or all of the 

guidance documents on the list. FDA 

has established a specific docket (see 

docket number found in brackets in the 

heading of this document) where 

comments about the FY 2009 list, draft 

language for guidance documents on 

those topics, and suggestions for new or 

different guidances may be submitted. 

FDA believes this docket is an 


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Federal Register / Vol. 73, No. 190 / Tuesday, September 30, 2008 / Notices 56831 

important tool for receiving information 

from interested parties and for sharing 

this information with the public. 

Similar information about planned 

guidance development is included in 

the annual agency-wide notice issued by 

FDA under its good guidance practices 

(§ 10.115(f)(5)). The CDRH list, however, 

will be focused exclusively on devicerelated guidances and will be made 

available on FDA’s Web site prior to the 

beginning of each FY from 2008 to 2012. 

To access the list of the guidance 

documents CDRH is considering for 

development in 2009, visit the FDA 

Web Site at http://www.fda.gov/cdrh/ 

mdufma/guidance/agenda/fy09.html. 

II. Request for 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. 

Comments submitted to this docket may 

include draft guidance documents that 

stakeholders have prepared for FDA’s 

consideration. 

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: September 24, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–22911 Filed 9–29–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0038] 

Antiviral Drugs Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). At least one portion of the 

meeting will be closed to the public. 

Name of Committee: Antiviral Drugs 

Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on October 30, 2008, from 9 a.m. 

to 1 p.m. 

Location: Hilton Washington DC/ 

Silver Spring, The Ballrooms, 1750 

Rockville Pike, Rockville, MD, 301– 

468–1100. 

Contact Person: Paul Tran, Center for 

Drug Evaluation and Research (HFD– 

21), Food and Drug Administration, 

5600 Fishers Lane (for express delivery, 

5630 Fishers Lane, rm. 1093), Rockville, 

MD 20857, 301–827–6793, FAX: 301– 

827–6776, e-mail: 

paul.tran@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512531. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: The meeting will be open to 

the public from 8 a.m. to 9 a.m., unless 

public participation does not last that 

long, from 9 a.m. to 1 p.m., the meeting 

will be closed to permit discussion of 

current and future advances on antiviral 

drugs which will include the review of 

trade secret and/or confidential 

information. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

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: On October 30, 2008, from 

8 a.m. to 9 a.m., the meeting is open to 

the public. 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 October 16, 2008. 

Oral presentations from the public will 

be scheduled between approximately 8 

a.m. and 9 a.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 October 7, 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 October 8, 2008. 

Closed Committee Deliberations: On 

October 30, 2008, from 9 a.m. to 1 p.m., 

the meeting will be closed to permit 

discussion and review of trade secret 

and/or confidential information (5 

U.S.C. 552b(c)(4)). During this session, 

the committee will be updated on 

current and future advances on antiviral 

drugs. 

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 Paul Tran 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: September 19, 2008. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E8–22912 Filed 9–29–08; 8:45 am] 

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