11116 Federal Register / Vol. 74, No. 49 / Monday, March 16, 2009 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

Meeting Requests and Information 

Packages 

No. of 

Respondents 

No. of Responses 

per Respondent 

Total Annual 

Responses 

Hours per 

Response Total Hours 

CDER 774 2.20 1,705 18 30,690 

CBER 120 1.65 198 18 3,564 

Total 34,254 

Grand Total 59,224 

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

Dated: March 9, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–5536 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–2008–N–0635] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Emergency 

Shortages Data Collection System 

(formerly ‘‘Emergency Medical Device 

Shortages Program Survey’’) 

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 April 15, 

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 0910–0491. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3793. 

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. 

Emergency Shortages Data Collection 

System (formerly ‘‘Emergency Medical 

Device Shortages Program Survey’’)— 

(Federal Food, Drug, and Cosmetic Act, 

Section 903 (d)(2) (OMB Control 

Number 0910–0491)—Extension 

Under section 903(d)(2) of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 393(d)(2)), the FDA 

Commissioner is authorized to 

implement general powers (including 

conducting research) to carry out 

effectively the mission of FDA. 

Subsequent to the events of September 

11, 2001, and as part of broader counterterrorism and emergency preparedness 

activities, FDA’s Center for Devices and 

Radiological Health (CDRH) began 

developing operational plans and 

interventions that would enable the 

Center to anticipate and respond to 

medical device shortages that might 

arise in the context of federally-declared 

disasters/emergencies or regulatory 

actions. In particular, CDRH identified 

the need to acquire and maintain 

detailed data on domestic inventory, 

manufacturing capabilities, distribution 

plans and raw material constraints for 

medical devices that would be in high 

demand, and/or would be vulnerable to 

shortages in specific disaster/emergency 

situations, or following specific 

regulatory actions. Such data could 

support prospective risk assessment, 

help inform risk mitigation strategies, 

and support real-time decision making 

by the Department of Health and Human 

Services during actual emergencies or 

emergency preparedness exercises. 

‘‘The Emergency Medical Device 

Shortage Program Survey’’ was 

developed in 2002 to support the 

acquisition of such data from medical 

device manufacturers. In 2004, CDRH 

changed the process for the data 

collection, and the electronic database 

in which the data were stored and was 

formally renamed the ‘‘Emergency 

Shortages Data Collection System’’ 

(ESDCS). Recognizing that some of the 

data collected may be commercially 

confidential, access to ESDCS is 

restricted to members of the FDA 

Emergency Shortage Team (EST) and 

senior management with a need-toknow. At this time, the need-to-know 

senior management personnel are 

limited to 5 senior managers. Further, 

the data are used by this defined group 

only for decision making and planning 

in the context of a federally-declared 

disaster/emergency, an official 

emergency preparedness exercise, or a 

potential public health risk posed by 

nondisaster-related device shortage. 

The data procurement process 

consists of an initial scripted telephone 

call to a regulatory officer at a registered 

manufacturer of one or more key 

medical devices being tracked in the 

emergency shortages data collection 

system. In this initial call, the intent and 

goals of the data collection effort are 

described, and the specific data request 

is made. After the initial call, one or 

more additional follow-up calls and/or 

electronic mail correspondence may be 

required to verify/validate data sent 

from the manufacturer, confirm receipt 

and/or request additional detail. 

Although the regulatory officer is the 

agent who is initially contacted, they 

may designate an alternate 

representative within their organization 

to correspond subsequently with the 

CDRH EST member who is collecting or 

verifying/validating the data. 

Because of the dynamic nature of the 

medical device industry, particularly 

with respect to specific product lines, 

manufacturing capabilities and raw 

material/subcomponent sourcing, it is 

necessary to update the data in the 

ESDCS at regular intervals. This is done 

on a weekly basis, but efforts are made 

to limit the frequency of outreach to a 

specific manufacturer to no more than 

every 4 months. 

The ESDCS will only include those 

medical devices for which there will 

likely be high demand during a specific 

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.