10256 Federal Register / Vol. 74, No. 45 / Tuesday, March 10, 2009 / Notices 

Section 10.33 (21 CFR 10.33) issued 

under section 701(a) of the Federal, 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 371(a)), sets forth the format 

and procedures by which an interested 

person may request reconsideration of 

part or all of a decision of the 

Commissioner on a petition submitted 

under 21 CFR 10.25 (initiation of 

administrative proceedings). A petition 

for reconsideration must contain a full 

statement in a well-organized format of 

the factual and legal grounds upon 

which the petition relies. The grounds 

must demonstrate that relevant 

information and views contained in the 

administrative record were not 

previously or not adequately considered 

by the Commissioner. The respondent 

must submit a petition no later than 30 

days after the decision involved. 

However, the Commissioner may, for 

good cause, permit a petition to be filed 

after 30 days. An interested person who 

wishes to rely on information or views 

not included in the administrative 

record shall submit them with a new 

petition to modify the decision. FDA 

uses the information provided in the 

request to determine whether to grant 

the petition for reconsideration. 

Respondents to this collection of 

information are individuals of 

households, State or local governments, 

not-for-profit institutions, and 

businesses or other for-profit 

institutions who are requesting from the 

Commissioner of FDA a reconsideration 

of a matter. 

Section 10.35 (21 CFR 10.35), issued 

under section 701(a) of the act, sets forth 

the format and procedures by which an 

interested person may request, in 

accordance with § 10.20 (submission of 

documents to Division of Dockets 

Management), the Commissioner to stay 

the effective date of any administrative 

action. 

Such a petition must do the following: 

(1) Identify the decision involved; (2) 

state the action requested, including the 

length of time for which a stay is 

requested; and (3) include a statement of 

the factual and legal grounds on which 

the interested person relies in seeking 

the stay. FDA uses the information 

provided in the request to determine 

whether to grant the petition for stay of 

action. 

Respondents to this information 

collection are interested persons who 

choose to file a petition for an 

administrative stay of action. 

Section 10.85 (21 CFR 10.85), issued 

under section 701(a) of the act, sets forth 

the format and procedures by which an 

interested person may request, in 

accordance with § 10.20 (submission of 

documents to Division of Dockets 

Management), an advisory opinion from 

the Commissioner on a matter of general 

applicability. An advisory opinion 

represents the formal position of FDA 

on a matter of general applicability. 

When making a request, the petitioner 

must provide a concise statement of the 

issues and questions on which an 

opinion is requested, and a full 

statement of the facts and legal points 

relevant to the request. Respondents to 

this collection of information are 

interested persons seeking an advisory 

opinion from the Commissioner on the 

agency’s formal position for matters of 

general applicability. 

In the Federal Register of December 

30, 2008 (73 FR 79885), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

10.30 162 3 486 12 5,832 

10.33 4 2 8 10 80 

10.35 7 2 14 10 140 

10.85 2 1 2 16 32 

Total 6,084 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The burden estimates for this 

collection of information are based on 

agency records and experience over the 

past 3 years. In 2007, FDA received 

approximately 162 citizen petitions 

(§ 10.30), 4 administrative 

reconsiderations of action (§ 10.33), 7 

administrative stays of action (§ 10.35), 

and 2 advisory opinions (§ 10.85). 

Dated: March 3, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–4972 Filed 3–9–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Endocrinologic and Metabolic 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). The meeting will be open to the 

public. 

Name of Committee: Endocrinologic 

and Metabolic 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 April 1 and 2, 2009, from 8 a.m. 

to 5 p.m. 

Location: Hilton Washington DC/ 

Silver Spring, The Ballrooms, 8727 

Colesville Rd., Silver Spring, MD. The 

hotel telephone number is 301–589– 

5200. 

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, 301–827–7001, FAX: 301– 

827–6776, e-mail: 

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

Advisory Committee Information Line, 

Federal Register / Vol. 74, No. 45 / Tuesday, March 10, 2009 / Notices 10257 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512536. 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: On April 1 and 2, 2009, two 

different new drug applications (NDAs), 

proposed for the treatment of 

hyperglycemia in adults with type 2 

diabetes mellitus will be discussed. On 

April 1, 2009, the committee will 

discuss NDA 22–350, saxagliptin 

tablets, Bristol-Myers Squibb, and on 

April 2, 2009, the committee will 

discuss NDA 22–341, liraglutide 

injection, Novo Nordisk, Inc. 

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 2009 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 March 23, 2009. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. on both days. 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 March 

16, 2009. 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 March 19, 2009. 

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: March 3, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–5024 Filed 3–9–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Oncologic 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). The meeting will be open to the 

public. 

Name of Committee: Oncologic 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 March 31, 2009, from 8:30 a.m. 

to 4:30 p.m. 

Location: Hilton Washington DC/ 

Silver Spring, The Ballrooms, 8727 

Colesville Rd., Silver Spring, MD. The 

hotel telephone number is 301–589– 

5200. 

Contact Person: Nicole Vesely, 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: 

nicole.vesely@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512542. 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 committee will discuss 

supplemental biologics license 

application (sBLA) 125085/169, 

AVASTIN (bevacizumab), Genentech, 

Inc., proposed indication as single agent 

for the treatment of previously treated 

glioblastoma multiforme. 

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 2009 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 March 20, 2009. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. to 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 March 16, 2009. 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 March 17, 2009.