Federal Register / Vol. 74, No. 9 / Wednesday, January 14, 2009 / Notices 2081 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Filing Objections and Requests for a 

Hearing on a Regulation or Order—21 

CFR Part 12 (OMB Control Number 

0910–0184)—Extension 

The regulations in 21 CFR 12.22, 

issued under section 701(e)(2) of the 

Federal Food, Drug, and Cosmetic Act 

(the act) (21 U.S.C. 371(e)(2)), set forth 

the instructions for filing objections and 

requests for a hearing on a regulation or 

order under § 12.20(d) (21CFR 12.20(d)). 

Objections and requests must be 

submitted within the time specified in 

§ 12.20(e). Each objection, for which a 

hearing has been requested, must be 

separately numbered and specify the 

provision of the regulation or the 

proposed order. In addition, each 

objection must include a detailed 

description and analysis of the factual 

information and any other document, 

with some exceptions, supporting the 

objection. Failure to include this 

information constitutes a waiver of the 

right to a hearing on that objection. FDA 

uses the description and analysis to 

determine whether a hearing request is 

justified. The description and analysis 

may be used only for the purpose of 

determining whether a hearing has been 

justified under 21 CFR 12.24 and do not 

limit the evidence that may be 

presented if a hearing is granted. 

Respondents to this information 

collection are those parties that may be 

adversely affected by an order or 

regulation. 

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 

12.22 5 1 5 20 100 

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

The burden estimate for this 

collection of information is based on 

past filings. Agency personnel, 

responsible for processing the filing of 

objections and requests for a public 

hearing on a specific regulation or order, 

estimate approximately five requests are 

received by the agency annually, with 

each requiring approximately 20 hours 

of preparation time. 

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: January 7, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–574 Filed 1–13–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Pulmonary-Allergy 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: PulmonaryAllergy 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 February 4, 2009, from 8:30 a.m. 

to 5 p.m. 

Location: Hilton Washington DC 

North/ Gaithersburg, The Ballrooms, 

620 Perry Pkwy., Gaithersburg, MD. The 

hotel telephone number is 301–977– 

8900. 

Contact Person: Kristine T. Khuc, 

Center for Drug Evaluation and Research 

(HFD–21), Food and Drug 

Administration, 5630 Fishers Lane (for 

express delivery, 5630 Fishers Lane,rm. 

1093), Rockville, MD 20857, 301–827– 

7001, Fax: 301–827–6776, e-mail: 

Kristine.Khuc@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512545. 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 

biologics license application (BLA) No. 

125277, KALBITOR, for ecallantide 

injection by Dyax Corp., for the 

proposed indication of treatment of 

acute attacks of hereditary angioedema. 

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 


sroberts on PROD1PC70 with NOTICES
2082 Federal Register / Vol. 74, No. 9 / Wednesday, January 14, 2009 / Notices 

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 January 23, 2009. 

Oral presentations from the public will 

be scheduled approximately between 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 January 21, 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 

January 22, 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 Kristine T. 

Khuc 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: January 8, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–686 Filed 1–13–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Center for Scientific 

Review Special Emphasis Panel, January 

26, 2009, 2 p.m. to January 26, 2009, 4 

p.m., National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD, 20892 

which was published in the Federal 

Register on December 31, 2008, 73 FR 

80417–80418. 

The meeting has been changed to an 

AED meeting starting January 26, 2009, 

8 a.m. to January 27, 2009, 5 p.m. The 

meeting title has been changed to 

‘‘Coagulation and Thrombosis’’. The 

meeting is closed to the public. 

Dated: January 6, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–403 Filed 1–13–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Clinical Center; Notice of 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 a meeting of the NIH 

Advisory Board for Clinical Research. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in section 

552b(c)(6), Title 5 U.S.C., as amended to 

discuss personnel matters, the 

disclosure of which would constitute a 

clearly unwarranted invasion of privacy. 

Name of Committee: NIH Advisory Board 

for Clinical Research. 

Date: January 26, 2009. 

Open: 10 a.m. to 1:15 p.m. 

Agenda: To review the strategic and 

operational issues of the NIH Intramural 

Research Program, including the Clinical 

Center. 

Place: National Institutes of Health, 

Building 10, 10 Center Drive, CRC Medical 

Board Room 4–2551, Bethesda, MD 20892, 

Closed: 1:15 p.m. to 2 p.m. 

Agenda: To discuss personnel matters. 

Place: National Institutes of Health, 

Building 10, 10 Center Drive, CRC Medical 

Board Room 4–2551, Bethesda, MD 20892. 

Contact Person: Maureen E. Gormley, 

Executive Secretary, Mark O. Hatfield 

Clinical Research Center, National Institutes 

of Health, Building 10, Room 6–2551, 

Bethesda, MD 20892, 301/496–2897. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

In the interest of security, NIH has 

instituted stringent procedures for entrance 

onto the NIH campus. All visitor vehicles, 

including taxicabs, hotel, and airport shuttles 

will be inspected before being allowed on 

campus. Visitors will be asked to show one 

form of identification (for example, a 

government-issued photo ID, driver’s license, 

or passport) and to state the purpose of their 

visit. 

Dated: January 7, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–515 Filed 1–13–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

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

is hereby given of a meeting of the 

National Cancer Institute Board of 

Scientific Advisors. 

The meeting will be open to the 

public, with attendance limited to space 

available. Individuals who plan to 

attend and need special assistance, such 

as sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

Name of Committee: National Cancer 

Institute Board of Scientific Advisors. 

Date: March 2–3, 2009. 

Time: March 2, 2009, 8 a.m. to 6 p.m. 

Agenda: Director’s Report: Ongoing and 

New Business; Reports of Program Review 

Group(s); and Budget Presentations; Reports 

of Special Initiatives; RFA and RFP Concept 

Reviews; and Scientific Presentations. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, 6th Floor, 

Conference Room 10, Bethesda, MD 20892. 


sroberts on PROD1PC70 with NOTICES