Federal Register / Vol. 74, No. 49 / Monday, March 16, 2009 / Notices 11119 

FOR FURTHER INFORMATION CONTACT: 

Robert Abugov, Center for Veterinary 

Medicine (HFV–105), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8168, 

Robert.abugov@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry #197 

entitled ‘‘Draft Guidance for Industry on 

Documenting Statistical Analysis 

Programs and Data Files.’’ This draft 

guidance provides recommendations to 

study statisticians for documenting 

statistical analyses and data files 

submitted to the Center for Veterinary 

Medicine (CVM) for the evaluation of 

safety and effectiveness in new animal 

drug applications. These 

recommendations are intended to 

reduce the number of revisions that may 

be required for CVM to effectively 

review statistical analyses and to 

simplify submission preparation by 

providing a uniform documentation 

system. 

II. Significance of Guidance 

This level 1 draft guidance is being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the agency’s 

current thinking on this topic. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

III. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 514 have 

been approved under OMB control no. 

0910–0032. 

IV. 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. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/cvm or http:// 

www.regulations.gov. 

Dated: March 10, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–5650 Filed 3–13–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Industry Exchange Workshop on Food 

and Drug Administration Drug and 

Device Requirements; Public 

Workshop 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) Chicago District, 

in cosponsorship with the Association 

of Food and Drug Officials (AFDO), is 

announcing a public workshop entitled 

‘‘Drugs and Devices—Promoting and 

Protecting the Public Health Through 

Risk Management and Product Cycle 

Improvement.’’ This 2-day public 

workshop is intended to provide 

information about FDA drug and device 

regulation to the regulated industry. 

Date and Time: The public workshop 

will be held on Monday, June 8, 2009, 

from 10:20 a.m. to 5 p.m. and Tuesday, 

June 9, 2009, from 8 a.m. to 5 p.m. 

Location: The public workshop will 

be held at the Doubletree Hotel 

Chicago—Oakbrook, 1909 Spring Rd., 

Oak Brook, IL 60523, 800–222–TREE, 

800–222–8733, or 630–472–6000, FAX: 

630–573–1909. 

Attendees are responsible for their 

own accommodations. To make 

reservations at the Doubletree Hotel 

Chicago—OakBrook, at the reduced 

conference rate, contact the Doubletree 

Hotel Chicago—OakBrook before May 5, 

2009, citing meeting code ‘‘AFDO 

Conference’’. 

Contact: William Weissinger, Food 

and Drug Administration, 550 W. 

Jackson Blvd., 15th Fl., Chicago, IL 

60661, 312–596–4210, FAX: 312–596– 

4242, e-mail: 

William.weissinger@fda.hhs.gov. 

Registration: You are encouraged to 

register by May 12, 2009. The AFDO 

registration fees cover the cost of 

facilities, materials, and breaks. Seats 

are limited; please submit your 

registration as soon as possible. Course 

space will be filled in order of receipt 

of registration. Those accepted into the 

course will receive confirmation. 

Registration will close after the course is 

filled. Registration at the site is not 

guaranteed but may be possible on a 

space available basis on the day of the 

public workshop beginning at 7:30 a.m. 

The cost of registration follows: 

COST OF REGISTRATION

Affiliation Fee 

Government (AFDO/North Central AFDO Member) $395.00 

Government (Non-Member) $495.00 

Non-Government (AFDO/ 

NCAFDO Member) $450.00 

Non-Government (Non-Member) $550.00 

To be added to registration fee 

for workshop registration 

postmarked after May 

12,2009 $75.00 

If you need special accommodations 

due to a disability, please contact 

William Weissinger at least 7 days in 

advance of the workshop. 

Registration instructions: To register, 

please submit your name, affiliation, 

mailing address, phone, fax number, 

and e-mail, along with a check or money 

order payable to ‘‘AFDO.’’ Please mail 

your payment to: AFDO, 2550 Kingston 

Rd., suite 311, York, PA 17402. To 

register via the Internet, go to 

www.afdo.org. (FDA has verified the 

Web site address, but is not responsible 

for subsequent changes to the Web site 

after this document publishes in the 

Federal Register). 

The registrar will also accept payment 

by major credit cards (VISA/MasterCard 

only). For more information on the 

meeting, or for questions on registration, 

contact AFDO, 717–757–2888, FAX: 

717–755–8089, or e-mail: 

afdo@afdo.org. 

SUPPLEMENTARY INFORMATION: The 

public workshop helps fulfill the 

Department of Health and Human 

Services’ and FDA’s important mission 

to protect the public health. The 

workshop will provide FDA-regulated 

drug and device entities with 

information on a number of topics 

concerning FDA requirements related to 

the production and marketing of drugs 

and/or devices. Topics for discussion 

include the following: 

11120 Federal Register / Vol. 74, No. 49 / Monday, March 16, 2009 / Notices 

∑ Risk management approach to 

consumer protection and industry 

regulation 

∑ How quality management systems 

(including corrective and preventive 

action) contribute to product cycle 

improvement 

∑ Supplier management and 

component controls for drugs and 

devices 

∑ Adverse drug event reporting 

requirements 

∑ Medical device reporting 

requirements 

∑ Recalls, corrections and removals 

∑ Complaint handling from the FDA 

investigator’s perspective. 

FDA has made education of the drug 

and device manufacturing community a 

high priority to help ensure the quality 

of FDA-regulated drugs and devices. 

The workshop helps to achieve 

objectives set forth in section 406 of the 

Food and Drug Administration 

Modernization Act of 1997 (21 U.S.C. 

393) which includes working closely 

with stakeholders and maximizing the 

availability and clarity of information to 

stakeholders and the public. The 

workshop also is consistent with the 

Small Business Regulatory Enforcement 

Fairness Act of 1996 (Public Law 104– 

121), as outreach activities by 

Government agencies to small 

businesses. 

Dated: March 4, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–5648 Filed 3–13–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Orthopaedic and Rehabilitation 

Devices Panel of the Medical Devices 

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: Orthopaedic and 

Rehabilitation Devices Panel of the 

Medical Devices 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 a.m. to 

5 p.m. 

Location: Hilton Washington DC 

North/Gaithersburg, Salons A, B, and C, 

620 Perry Pkwy., Gaithersburg, MD. 

Contact Person: Ronald P. Jean, 

Center for Devices and Radiological 

Health (HFZ–410), Food and Drug 

Administration, 9200 Corporate Blvd., 

Rockville, MD, 20850, 240–276–3676, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), code 

3014512521. 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, 

make recommendations, and vote on a 

premarket approval application (PMA) 

for OP-1 Putty, sponsored by Stryker 

Biotech. This combination product is 

indicated for posterolateral spinal 

fusion procedures in skeletally mature 

patients with lumbar spondylolisthesis 

who have failed at least 6 months of 

conservative nonsurgical treatment. 

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 24, 2009. 

Oral presentations from the public will 

be scheduled for 30 minutes at the 

beginning of the committee 

deliberations and for 30 minutes near 

the end of the deliberations. 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 

20, 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 23, 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 AnnMarie 

Williams, Conference Management 

Staff, 240–276–8932, 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 10, 2009. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E9–5644 Filed 3–13–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

is hereby given of the following 

meetings. 

The meetings 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