Federal Register / Vol. 74, No. 63 / Friday, April 3, 2009 / Notices 15295 

(2) Specialists. This cohort includes 

office-based practitioners in 

rheumatology with at least 3 years of 

experience and who engage in patient 

care at least 50 percent of the time. 

Cohorts will be identified and 

recruited to represent a reasonable range 

of age, gender, and ethnicity. 

Within each cohort, 20 practitioners 

will be interviewed by trained 

interviewers in one-on-one in-depth 

telephone interviews. A sample size of 

40 (approximately 20 primary care 

providers and 20 rheumatologists) is 

sufficiently large for the qualitative 

findings to capture a wide depth and 

range of people’s thinking. The 

interviews will take approximately 45 

minutes. The health care provider 

interviews will be used to create a 

mental model of physician 

decisionmaking factors with respect to 

drug product effectiveness. 

Potential physician participants will 

be randomly identified through a 

purchased list based on the American 

Medical Association’s (AMA) Physician 

Masterfile. This list tracks all 

physicians, M.D. (doctor of medicine) 

and DO (doctor of osteopathic 

medicine), practicing in the United 

States, not only members of the AMA. 

FDA intends this collection to be used 

as formative research. As with our focus 

group research (OMB control number 

0910–0360), the results of this formative 

research will provide direction toward 

potential areas of focus. Further 

research is necessary, and planned, to 

test concepts obtained from these 

results. This research will be useful in 

designing survey questions for the next 

phases of this research project (which 

will be submitted for approval at a later 

date). 

In the Federal Register of November 

24, 2008 (73 FR 71006), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours Per 

Response Total Hours 

21 U.S.C. 393(b)(2)(c) Questionnaire, Pretesting 4 1 4 .75 3 

21 U.S.C. 393(b)(2)(c) Questionnaire, Study 40 1 40 .75 30 

Total 33 

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

Dated: March 27, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–7471 Filed 4–2–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0653] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Filing Objections 

and Requests for a Hearing on a 

Regulation or Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by May 4, 

2009. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0184. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Filing Objections and Requests for a 

Hearing on a Regulation or Order— 

(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) (21 CFR 

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. 

In the Federal Register of January 14, 

2009 (74 FR 2080), 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: 


sroberts on PROD1PC70 with NOTICES
15296 Federal Register / Vol. 74, No. 63 / Friday, April 3, 2009 / Notices 

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. 

Dated: March 27, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–7472 Filed 4–2–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the President’s Cancer 

Panel, March 23, 2009, 12:30 p.m. to 

March 23, 2009, 3 p.m., National 

Institutes of Health, 6116 Executive 

Boulevard, Rockville, MD 20852 which 

was published in the Federal Register 

on March 19, 2009, 74 FR 11741. 

This meeting is being amended to 

reschedule the meeting to Tuesday, 

March 31, 2009, 10 a.m. to 12:30 p.m. 

as a telephone conference. The meeting 

is closed to the public. 

Dated: March 25, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–7318 Filed 4–2–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Complementary & 

Alternative Medicine; Amended Notice 

of Meeting 

Notice is hereby given of a change in 

the meeting of the National Center for 

Complementary and Alternative 

Medicine Special Emphasis Panel, 

March 24, 2009, 8 a.m. to March 25, 

2009, 5 p.m., National Institutes of 

Health, Two Democracy Plaza, 6707 

Democracy Boulevard, Bethesda, MD 

20892 which was published in the 

Federal Register on February 17, 2009, 

74 FR 7452. 

This meeting is being amended to 

reschedule the meeting to April 13–14, 

2009 from 8 a.m. to 5 p.m. The meeting 

is closed to the public. 

Dated: March 24, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–7263 Filed 4–2–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), 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 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Alcohol Abuse and Alcoholism, Special 

Emphasis Panel. AA3 Deferred Applications. 

Date: April 22, 2009. 

Time: 2 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: NIH/NIAAA, 5635 Fishers Lane, 

Bethesda, MD 20892 (Telephone Conference 

Call). 

Contact Person: Katrina L Foster, PhD, 

Scientific Review Officer, National Inst on 

Alcohol Abuse & Alcoholism, National 

Institutes of Health, 5635 Fishers Lane, Rm. 

2019, Rockville, MD 20852, 301–443–4032. 

katrina@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.271, Alcohol Research 

Career Development Awards for Scientists 

and Clinicians; 93.272, Alcohol National 

Research Service Awards for Research 

Training; 93.273, Alcohol Research Programs; 

93.891, Alcohol Research Center Grants, 

National Institutes of Health, HHS) 

Dated: March 25, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–7319 Filed 4–2–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Notice of a Conference Call of a 

Working Group of the NIH Blue Ribbon 

Panel 

The purpose of this notice is to inform 

the public about a conference call of the 

NIH Blue Ribbon Panel to Advise on the 

Risk Assessment of the National 

Emerging Infectious Diseases 

Laboratories at Boston University 

Medical Center. This meeting is the first 

in a series of public meetings to review 

and discuss the ongoing supplementary 

risk assessment study. 

The conference call will be held on 

Tuesday, April 7, 2009 from 

approximately 11 a.m. to 1 p.m. The 

toll-free number to participate in the 

call is 1–800–779–2616. Indicate to the 

conference operator that your 

participant passcode is ‘‘NIH.’’ 

The panel will review earlier National 

Research Council (NRC) 

recommendations regarding a 

supplementary risk assessment study, 

Blue Ribbon Panel recommendations 

regarding various aspects of the risk 

assessment study, and a new Statement 

of Task for the NRC. 

Public comment will begin at 

approximately 12:45 p.m. In the event 

that time does not allow for all those 

interested to present oral comments, 

anyone may file written comments by 

sending them to the address below. 

Comments should include the name, 

address, telephone number and when 

applicable, the business or professional 

affiliation of the commenter. 

A draft agenda and slides for the 

meeting may be obtained by connecting 

to http://nihblueribbonpanel-bumcVerDate Nov<24>2008 16:07 Apr 02, 2009 Jkt 217001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\03APN1.SGM 03APN1

sroberts on PROD1PC70 with NOTICES