24718 Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Notices 

computer with access to the Internet. 

Updated on a regular basis, the CDRH 

home page includes the guidance as 

well as the current list of recognized 

standards and other standards related 

documents. After publication in the 

Federal Register, this notice 

announcing ‘‘Modification to the List of 

Recognized Standards, Recognition List 

Number: 023’’ will be available on the 

CDRH home page. You may access the 

CDRH home page at http://www.fda.gov/ 

cdrh. 

You may access ‘‘Guidance on the 

Recognition and Use of Consensus 

Standards,’’ and the searchable database 

for ‘‘FDA Recognized Consensus 

Standards’’ through the hyperlink at 

http://www.fda.gov/cdrh/stdsprog.html. 

This Federal Register document on 

modifications in FDA’s recognition of 

consensus standards is available at 

http://www.fda.gov/cdrh/fedregin.html. 

VII. Submission of Comments and 

Effective Date 

Interested persons may submit to the 

contact person (see FOR FURTHER

INFORMATION CONTACT) written or 

electronic comments regarding this 

document. Two copies of any mailed 

comments are to be submitted, 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. FDA will consider any 

comments received in determining 

whether to amend the current listing of 

modifications to the list of recognized 

standards, Recognition List Number: 

023. These modifications to the list or 

recognized standards are effective upon 

publication of this notice in the Federal 

Register. 

Dated: April 30, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10562 Filed 5–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0052] 

Guidance for Industry on Documenting 

Statistical Analysis Programs and Data 

Files; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

#197 entitled ‘‘Documenting Statistical 

Analysis Programs and Data Files.’’ This 

guidance is provided to inform study 

statisticians of recommendations 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 

encompass the most complex data 

submissions to CVM, 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. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

Submit written comments on the 

guidance 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. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Anna Nevius, Center for Veterinary 

Medicine (HFV–163), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–276–8170, 

anna.nevius@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of March 16, 

2009 (74 FR 11118), FDA published the 

notice of availability for a draft guidance 

entitled ‘‘Draft Guidance for Industry on 

Documenting Statistical Analysis 

Programs and Data Files; Availability’’ 

giving interested persons until June 1, 

2009, to comment on the draft guidance. 

FDA received no comments on the draft 

guidance. Minor editorial changes were 

made to improve clarity. The guidance 

announced in this notice finalizes the 

draft guidance dated April 27, 2009. 

II. Significance of Guidance 

This level 1 guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on the 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 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 

Submit written requests for single 

copies of the guidance to the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. 

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 guidance at either http:// 

www.fda.gov/AnimalVeterinary/ 

default.htm or http:// 

www.regulations.gov. 

Dated: April 29, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10582 Filed 5–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0224] 

Town Hall Discussion With the Director 

of the Center for Devices and 

Radiological Health and Other Senior 

Center Management 

AGENCY: Food and Drug Administration, 

HHS 


sroberts on DSKD5P82C1PROD with NOTICES
Federal Register / Vol. 75, No. 86 / Wednesday, May 5, 2010 / Notices 24719 

ACTION: Notice of public meeting; 

request for comments. 

The Food and Drug Administration 

(FDA) is announcing a public meeting 

entitled ‘‘Town Hall Discussion With the 

Director of the Center for Devices and 

Radiological Health and Other Senior 

Center Management.’’ The purpose of 

this meeting is to present the Center for 

Devices and Radiological Health (CDRH) 

fiscal year (FY) 2010 priorities. In 

addition, FDA is interested in engaging 

in discussions about issues that are of 

importance to the medical device 

industry. 

Date and Time: The public meeting 

will be held on June 22, 2010, from 9 

a.m. to 5 p.m. 

Location: The public meeting will be 

held at the Hilton Boston/Woburn, Two 

Forbes Rd., Woburn, MA 01801. The 

meeting will not be videotaped or Web 

cast. 

Contact: Heather Howell, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, rm. 4320, 

Silver Spring, MD 20993, 301–796– 

5718, e-mail: 

heather.howell@fda.hhs.gov. 

Registration and Requests for Oral 

Presentations: If you wish to attend the 

public meeting, you must register online 

at: http://www.fda.gov/MedicalDevices/ 

NewsEvents/WorkshopsConferences/ 

ucm206671.htm. Provide complete 

contact information for each attendee, 

including name, title, company or 

organization, address, e-mail, and 

telephone number. Registration requests 

must be received by 5 p.m. on 

Wednesday, June 9, 2010. 

If you wish to make an oral 

presentation during any of the sessions 

at the meeting (see section II of this 

document), you must indicate this at the 

time of registration. FDA will do its best 

to accommodate requests to speak. 

Individuals and organizations with 

common interests are urged to 

consolidate or coordinate their 

presentations, and to request time for a 

joint presentation. FDA will determine 

the amount of time allotted to each 

presenter and the approximate time that 

each oral presentation is scheduled to 

begin. 

Registration is free and will be on a 

first-come, first-served basis. Early 

registration is recommended because 

seating is limited. FDA may limit the 

number of participants from each 

organization based on space limitations. 

Registrants will receive confirmation 

once they have been accepted. Onsite 

registration on the day of the public 

meeting will be provided on a spaceavailable basis beginning at 8 a.m. 

If you need special accommodations 

due to a disability, please contact Susan 

Monahan at 301–796–5661 or e-mail: 

susan.monahan@fda.hhs.gov at least 7 

days in advance of the meeting. 

Comments: FDA is holding this public 

meeting to share information and 

discuss issues of importance to the 

medical device industry. CDRH is 

specifically interested in addressing the 

following question: What mechanism(s) 

would you prefer or suggest for FDA to 

engage with industry? The deadline for 

responding to this question and for 

submitting other comments related to 

this public meeting is Wednesday, June 

9, 2010. 

Regardless of attendance at the public 

meeting, interested persons may submit 

written or electronic comments. 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. 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. 

SUPPLEMENTARY INFORMATION: 

I. Background 

CDRH has announced four priority 

areas of activity for FY 2010, each of 

which presents significant opportunities 

to improve CDRH’s effectiveness in 

fulfilling our public health mission. 

More information, including specific 

goals and actions associated with each 

priority, is available under ‘‘CDRH 

Strategic Planning’’ at http:// 

www.fda.gov/AboutFDA/CentersOffices/ 

CDRH. 

II. Public Meeting 

The objective of this public meeting is 

to present CDRH’s FY 2010 priorities. In 

addition, FDA is interested in engaging 

in discussions about issues that are of 

importance to the medical device 

industry. CDRH wishes to obtain 

feedback/ideas for facilitating two-way 

communication between CDRH and the 

medical device industry. 

The meeting will open with an 

introduction of CDRH Senior Staff in 

attendance. Following introductions, Dr. 

Jeffrey Shuren, the Director of CDRH, 

will present the FY 2010 CDRH 

priorities. Industry representatives and 

other members of the public will then 

be given the opportunity to present 

comments to CDRH Senior Staff. 

Attendees from CDRH may respond to 

questions presented by industry and 

other members of the public. 

In advance of the meeting, additional 

information, including a meeting agenda 

with a speakers’ schedule, will be made 

available on the Internet. This 

information will be placed on file in the 

public docket (docket number found in 

brackets in the heading of this 

document), which is available at http:// 

www.regulations.gov. This information 

will also be available at http:// 

www.fda.gov/MedicalDevices/ 

NewsEvents/WorkshopsConferences/ 

default.htm (select the appropriate 

meeting from the list). 

III. Transcripts 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD. A transcript will 

also be available in either hardcopy or 

on CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to Division of 

Freedom of Information (HFI–35), Office 

of Management Programs, Food and 

Drug Administration, 5600 Fishers 

Lane, rm. 6–30, Rockville, MD 20857. 

Dated: April 30, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10563 Filed 5–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0002] 

Withdrawal of Approval of New Animal 

Drug Applications; Coumaphos; 

Novobiocin; Buquinolate and 

Lincomycin 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of three new animal drug 

applications (NADAs). In a final rule 

published elsewhere in this issue of the 

Federal Register, FDA is amending the 

animal drug regulations to remove 

portions reflecting approval of the single 

NADA of the three that is codified. 

DATES: Withdrawal of approval is 

effective May 17, 2010. 


sroberts on DSKD5P82C1PROD with NOTICES