11118 Federal Register / Vol. 74, No. 49 / Monday, March 16, 2009 / Notices 

CDRH maintains an entry on the 

Internet for easy access to information 

including text, graphics, and files that 

may be downloaded to a personal 

computer with Internet access. Updated 

on a regular basis, the CDRH home page 

includes device safety alerts, Federal 

Register reprints, information on 

premarket submissions (including lists 

of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

at http://www.regulations.gov or the 

CBER Internet site at http:// 

www.fda.gov/cber/guidelines.htm. 

IV. Paperwork Reduction Act of 1995 

Under the Paperwork Reduction Act 

of 1995 (the PRA) (44 U.S.C. 3501– 

3520), Federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

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. 

Title: User Fees and Refunds for 

Premarket Approval Applications. 

Description: Section 738 of the act 

requires the payment of user fees for 

devices subject to premarket approval 

(PMA) under section 515 of the act (21 

U.S.C. 360e). Section 738(j) of the act 

allows for refunds of these fees in 

certain circumstances. This draft 

guidance document describes 

requirements associated with user fees 

and FDA’s recommendation for the kind 

of information to include in a request 

for a refund. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Federal Food, Drug, and Cosmetic Act No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

738(j) 17 1 17 0.5 9 

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

The industry-wide burden estimate is 

based on an FDA actual average fiscal 

year (FY) annual rate of receipt of 17 

refund requests, using FY 2005 through 

2007 data. 

This draft guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR part 814, subparts B and E have 

been approved under OMB control 

number 0910–0231. 

V. 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. 

Dated: March 4, 2009. 

Daniel G. Schultz, 

Director, Center for Devices and Radiological 

Health. 

[FR Doc. E9–5543 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–D–0052] 

Draft 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 draft guidance for 

industry #197 entitled ‘‘Draft Guidance 

for Industry on Documenting Statistical 

Analysis Programs and Data Files.’’ The 

purpose of this draft guidance is to 

simplify the preparation and evaluation 

of submissions in support of new 

animal drug applications by providing a 

uniform system for documenting 

statistical analysis programs and data 

files. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by June 1, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft 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 draft 

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 draft guidance 

document. 

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: