Federal Register / Vol. 74, No. 44 / Monday, March 9, 2009 / Notices 10053 

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 8, 

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 0910–0138. 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. 

Reclassification Petitions for Medical 

Devices—21 CFR Section 860.123 (OMB 

Control Number 0910–0138)—Extension 

FDA has responsibility under sections 

513(e) and (f), 514(b), 515(b), and 520(l) 

of the Federal Food, Drug, and Cosmetic 

Act (the act) (21 U.S.C. 360c(e), and (f), 

360d(b), 360e(b), and 360j(l)) and part 

860 (21 CFR part 860), subpart C, to 

collect data and information contained 

in reclassification petitions. The 

reclassification provisions of the act 

allow any person to petition for 

reclassification of a device from any one 

of the three classes i.e, I, II, and III, to 

another class. The reclassification 

procedure regulation requires the 

submission of specific data when a 

manufacturer is petitioning for 

reclassification. This includes a 

‘‘Supplemental Data Sheet,’’ Form FDA 

3427, and a ‘‘Classification 

Questionnaire,’’ Form FDA 3429. Both 

forms are a series of questions 

concerning the safety and effectiveness 

of the device type. Further, the 

reclassification content regulation 

(§ 860.123) requires the submission of 

sufficient, valid scientific evidence 

demonstrating that the proposed 

reclassification will provide a 

reasonable assurance of safety and 

effectiveness of the device type for its 

indications for use. Thus, the 

reclassification provisions of the act 

serve primarily as a vehicle for 

manufacturers to seek reclassification 

from a higher to a lower class, thereby 

reducing the regulatory requirements 

applicable to a particular device type, or 

to seek reclassification from a lower to 

a higher class, thereby increasing the 

regulatory requirements. The 

reclassification petitions requesting 

classification from class III to class II or 

class I, if approved, provides an 

alternative route to the market in lieu of 

premarket approval for class III devices 

or from class I or II, to one or the other 

class, which may increase requirements. 

In the Federal Register of December 4, 

2008 (73 FR 73938), 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

21 CFR Section No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

860.123 6 1 6 500 3,000 

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

Based on the last 3 years, and actual 

reclassification petitions received, FDA 

anticipates that six petitions will be 

submitted each year. The time required 

to prepare and submit a reclassification 

petition, including the time needed to 

assemble supporting data, averages 500 

hours per petition. This average is based 

upon estimates by FDA administrative 

and technical staff that: (1) Are familiar 

with the requirements for submission of 

a reclassification petition, (2) have 

consulted and advised manufacturers on 

these requirements, and (3) have 

reviewed the documentation submitted. 

Dated: March 2, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–4829 Filed 3–6–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0098] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Evaluation of 

Potential Data Sources for the Sentinel 

Initiative 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the proposed information collection 

through a survey designed to identify 

potential data sources and/or data 

environments that could participate in 

the Sentinel Initiative to create a 

national, electronic distributed system, 

strengthening FDA’s ability to monitor 

the postmarket performance of a 

medical product. 

DATES: Submit written or electronic 

comments on the collection of 

information by May 8, 2009. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 


dwashington3 on PROD1PC60 with NOTICES
10054 Federal Register / Vol. 74, No. 44 / Monday, March 9, 2009 / Notices 

1 Institute of Medicine, ‘‘The Future of Drug 

Safety—Promoting and Protecting the Health of the 

Public,’’ September 22, 2006, http://www.iom. 

edu/. (FDA has verified the Web site address, but 

FDA is not responsible for any subsequent changes 

to the Web site after this document publishes in the 

Federal Register.) 

2Food and Drug Administration Amendments 

Act of 2007, Public Law 110–85, was signed into 

law in September 2007. See Title IX, Section 905. 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. To 

obtain a copy of the draft survey 

instrument contact Tomeka Arnett on 

301–827–1512. 

SUPPLEMENTARY INFORMATION: Under 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. 

Evaluation of Potential Data Sources for 

the Sentinel Initiative 

In September 2005, the Secretary of 

Health and Human Services (the 

Secretary) asked FDA to expand its 

current system for monitoring medical 

product performance. The Secretary 

asked FDA to explore the possibility of 

working in collaboration with multiple 

healthcare data systems to augment 

FDA’s capability of identifying and 

evaluating product safety information 

beyond its existing voluntary reporting 

systems. Such a step would strengthen 

FDA’s ability, ultimately, to monitor the 

performance of a product after 

marketing approval. The Secretary 

recommended that FDA explore creating 

a public-private collaboration as a 

framework for such an effort leveraging 

increasingly available large, electronic 

healthcare databases and taking 

advantage of emerging technologies and 

building on existing systems and efforts, 

rather than creating new systems. 

In 2006, the Institute of Medicine 

(IOM) issued a report entitled ‘‘The 

Future of Drug Safety—Promoting and 

Protecting the Health of the Public.’’1

Among other suggestions, this IOM 

report recommended FDA identify ways 

to access other health-related databases 

and create a public-private partnership 

to support safety and efficacy studies. 

In 2007, Congress enacted the Food 

and Drug Administration Amendments 

Act of 20072 (FDAAA). Section 905 of 

FDAAA calls for the Secretary to 

develop methods to obtain access to 

disparate data sources and to establish 

an active postmarket risk identification 

and analysis system that links and 

analyzes healthcare data from multiple 

sources. The law sets a goal of access to 

data from 25 million patients by July 1, 

2010, and 100 million patients by July 

1, 2012. The law also requires FDA to 

work closely with partners from public, 

academic, and private entities. FDA 

views the Sentinel Initiative as a 

mechanism through which this mandate 

can be carried out. 

Consistent with FDA’s mission to 

protect and promote the public health, 

FDA is embarking on the Sentinel 

Initiative to create a national, electronic 

distributed system, strengthening FDA’s 

ability to monitor the post-market 

performance of a product. As currently 

envisioned, the Sentinel Initiative will 

enable FDA to capitalize on the 

capabilities of multiple, existing data 

systems (e.g. electronic health record 

systems and medical claims databases) 

to augment the agency’s current 

surveillance capabilities. The proposed 

system will enable queries of distributed 

data sources quickly and securely for 

relevant product safety information. 

Data will continue to be managed by its 

owners, and only data of organizations 

who agree to participate in this system 

will be included. Operations will adhere 

to strict privacy and security safeguards. 

The success of this Initiative will 

depend largely on the content, quality, 

searchability, and responsiveness of 

participating data sources and/or data 

environments. It is essential that FDA 

understand the strengths and limitations 

of potential data sources that might be 

included in the Sentinel Initiative. This 

survey will be used to collect 

information from potentially 

participating data sources and/or 

environments. The data we are seeking 

will describe the characteristics of the 

data available, not personally 

identifiable information. The findings 

will help FDA plan for this proposed 

system and for future work related to 

the Sentinel Initiative. 

This survey will collect information 

on the scope, content, structure, quality, 

and timeliness of data; patient 

population(s), duration of follow up, 

and capture of care across all settings; 

availability, experience, and interest of 

investigators with knowledge of the data 

in using it for post-market product 

safety surveillance as well as plans for 

further data source enhancements; 

availability, experience, and interest of 

investigators with knowledge of the data 

in participating in a distributed data 

system; and barriers that exist to 

including each data source in the 

Sentinel Initiative. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Activity No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Data Source and/or Environment 

Survey 250 1 250 24.5 6,125 

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


dwashington3 on PROD1PC60 with NOTICES
Federal Register / Vol. 74, No. 44 / Monday, March 9, 2009 / Notices 10055 

FDA estimates that approximately 250 

respondents will participate in this 

voluntary survey. These respondents 

will consist mostly of other Federal 

agencies, health plan data sources, 

health information exchanges, large 

multi-specialty medical groups and 

academic medical centers, large hospital 

systems, pharmacies, medical societies, 

consumer-oriented Web sites, 

commercial data sets, research 

networks, lab data, and registries. 

Each respondent will extend 

approximately 24.5 hours to complete 1 

survey for a total of 6,125 hours (250 x 

1 x 24.5 = 6,125). 

Dated: February 27, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–4830 Filed 3–6–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–E–0164] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ALTABAX OINTMENT 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

ALTABAX OINTMENT and is 

publishing this notice of that 

determination as required by law. FDA 

has made the determination because of 

the submission of an application to the 

Director of Patents and Trademarks, 

Department of Commerce, for the 

extension of a patent which claims that 

human drug product. 

ADDRESSES: Submit written comments 

and petitions 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. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

rm. 6222, Silver Spring, MD 20993– 

0002, 301–796–3602. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Public Law 98– 

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 100–670) generally provide that a 

patent may be extended for a period of 

up to 5 years so long as the patented 

item (human drug product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the human drug 

product becomes effective and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the human drug product and continues 

until FDA grants permission to market 

the drug product. Although only a 

portion of a regulatory review period 

may count toward the actual amount of 

extension that the Director of Patents 

and Trademarks may award (for 

example, half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA recently approved for marketing 

the human drug product ALTABAX 

OINTMENT (retapamulin). ALTABAX 

OINTMENT is indicated for the topical 

treatment of impetigo due to 

Staphylococcus aureus (methicillinsusceptible isolates only) or 

Streptococcus pyogenes in patients aged 

9 months or older. Subsequent to this 

approval, the Patent and Trademark 

Office received a patent term restoration 

application for ALTABAX OINTMENT 

(U.S. Patent No. RE39,128E) from 

SmithKline Beecham P.L.C., and 

SmithKline Beecham Corp., and the 

Patent and Trademark Office requested 

FDA’s assistance in determining this 

patent’s eligibility for patent term 

restoration. In a letter dated April 28, 

2008, FDA advised the Patent and 

Trademark Office that this human drug 

product had undergone a regulatory 

review period and that the approval of 

ALTABAX OINTMENT represented the 

first permitted commercial marketing or 

use of the product. Thereafter, the 

Patent and Trademark Office requested 

that FDA determine the product’s 

regulatory review period. 

FDA has determined that the 

applicable regulatory review period for 

ALTABAX OINTMENT is 1,602 days. 

Of this time, 1,297 days occurred during 

the testing phase of the regulatory 

review period, while 305 days occurred 

during the approval phase. These 

periods of time were derived from the 

following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (the act) (21 U.S.C. 

355(i)) became effective: November 24, 

2002. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on November 24, 2002. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: June 12, 2006. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

ALTABAX OINTMENT (NDA 22–055) 

was initially submitted on June 12, 

2006. 

3. The date the application was 

approved: April 12, 2007. FDA has 

verified the applicant’s claim that NDA 

22–055 was approved on April 12, 2007. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its application for patent extension, 

this applicant seeks 833 days of patent 

term extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments and ask for a 

redetermination by May 8, 2009. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

September 8, 2009. To meet its burden, 

the petition must contain sufficient facts 

to merit an FDA investigation. (See H. 

Rept. 857, part 1, 98th Cong., 2d sess., 

pp. 41–42, 1984.) Petitions should be in 

the format specified in 21 CFR 10.30. 

Comments and petitions should be 

submitted to the Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. Comments and petitions may 

be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 


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