Federal Register / Vol. 74, No. 49 / Monday, March 16, 2009 / Notices 11117 

emergency/disaster, or for which there 

are sufficiently small numbers of 

manufacturers such that disruption of 

manufacture or loss of one or more of 

these manufacturers would create a 

shortage. 

In the Federal Register of December 

19, 2008 (73 FR 77718), 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: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Section of the Act No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

903(d)(2) 125 3 375 0.5 188 

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

FDA based the burden estimates in 

Table 1 on past experience with direct 

contact with the medical device 

manufacturers, and anticipated changes 

in the medical device manufacturing 

patterns for the specific devices being 

monitored. FDA estimates that 

approximately 125 manufacturers 

would be contacted by telephone and/ 

or electronic mail 3 times per year to 

either obtain primary data or to verify/ 

validate data. Because the data being 

requested represent data elements that 

are monitored or tracked by 

manufacturers as part of routine 

inventory management activities, it is 

anticipated that for most manufacturers, 

the estimated time required of 

manufacturers to complete the data 

request will not exceed 30 minutes per 

request cycle. 

Dated: March 9, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–5545 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–0051] 

Draft Guidance for Industry and Food 

and Drug Administration; User Fees 

and Refunds for Premarket Approval 

Applications; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘User Fees and Refunds for 

Premarket Approval Applications’’ 

(PMAs). The purpose of this draft 

guidance document is to outline the 

types of PMAs subject to user fees, 

including supplements and other 

submissions, as well as those that do not 

have an associated user fee. The draft 

guidance also identifies industry and 

FDA actions on these submissions that 

may result in a refund of the fee. 

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 April 15, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘User Fees and 

Refunds for Premarket Approval 

Applications,’’ to the Division of Small 

Manufacturers, International, and 

Consumer Assistance (HFZ–220), Center 

for Devices and Radiological Health, 

Food and Drug Administration, 1350 

Piccard Dr., Rockville, MD 20850, or to 

the Office of Communication, Training, 

and Manufacturers Assistance (HFM– 

40), Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448. 

The draft guidance may also be obtained 

by mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. Send one selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 240–276–3151. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. 

Submit written comments concerning 

this 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. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Nicole Wolanski, Center for Devices 

and Radiological Health (HFZ–402), 

Food and Drug Administration, 

9200 Corporate Blvd., Rockville, 

MD 20850, 240–276–4010. 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 

5515 Security Lane, rm. 130, 

Rockville, MD 20852, 301–827– 

6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Medical Device User Fee and 

Modernization Act of 2002 (MDUFMA) 

(Public Law 107–250) amends the 

Federal Food, Drug, and Cosmetic Act 

(the act) to provide FDA new 

responsibilities and resources associated 

with the collection and refund of user 

fees. The primary difference between 

this draft guidance and the November 

24, 2003, version now in effect is the 

addition of user fee and user fee refund 

information for 30-day notices and 

periodic reports. Additionally, the draft 

guidance discusses the modified user 

fee refund provisions for modular 

PMAs. If finalized, this draft guidance 

will supersede the 2003 guidance. 

II. Significance of Guidance 

This 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 user fees and refunds for premarket 

approval applications. 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 statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by using 

the Internet. To receive ‘‘User Fees and 

Refunds for Premarket Approval 

Applications,’’ you may either send an 

e-mail request to dsmica@fda.hhs.gov to 

receive an electronic copy of the 

document, or send a fax request to 240– 

276–3151 to receive a hard copy. Please 

use the document number (1681) to 

identify the guidance you are 

requesting. 

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.