Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices 61493 

their intended audiences. Testing 

messages with a sample of the target 

audience will allow FDA to refine 

messages while still in the 

developmental stage. Respondents will 

be asked to give their reaction to the 

messages in either individual or group 

settings. 

Third, as evaluative research, it will 

allow FDA to ascertain the effectiveness 

of the messages and the distribution 

method of these messages in achieving 

the objectives of the message campaign. 

Evaluation of campaigns is a vital link 

in continuous improvement of 

communications at FDA. 

FDA estimates the burden of this 

collection of information based on 

recent prior experience with the various 

types of data collection methods 

described above: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

21 CFR 1003(d)(2)(D) 16,448 1 16,448 0.1739 2,860 

Total 16,448 1 16,448 0.1739 2,860 

1There are no capital costs associated with this collection of information. 

Dated: September 30, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–25011 Filed 10–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0468] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Patent Term 

Restoration, Due Diligence Petitions, 

Filing, Format, and Content of 

Petitions 

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, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

FDA’s patent term restoration 

regulations on due diligence petitions 

for regulatory review period revision. 

Where a patented product must receive 

FDA approval before marketing is 

permitted, the Office of Patents and 

Trademarks may add a portion of the 

FDA review time to the term of a patent. 

Petitioners may request reductions in 

the regulatory review time if FDA 

marketing approval was not pursued 

with ‘‘due diligence.’’ 

DATES: Submit either electronic or 

written comments on the collection of 

information by December 6, 2010. 

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: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

P150–400B, Rockville, MD 20850, 301– 

796–3792, 

Elizabeth.Berbakos@fda.hhs.gov. 

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, 

including each proposed extension of an 

existing 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. 

Patent Term Restoration, Due Diligence 

Petitions, Filing, Format, and Content of 

Petitions—21 CFR Part 60 (OMB 

Control Number 0910–0233)—Extension 

FDA’s patent extension activities are 

conducted under the authority of the 

Drug Price Competition and Patent 

Term Restoration Act of 1984 (21 U.S.C. 

355(j)) and the Animal Drug and Patent 

Term Restoration Act of 1988 (35 U.S.C. 

156). New human drug, animal drug, 

human biological, medical device, food 

additive, or color additive products 

regulated by FDA must undergo FDA 

safety, or safety and effectiveness, 

review before marketing is permitted. 

Where the product is covered by a 

patent, part of the patent’s term may be 

consumed during this review, which 

diminishes the value of the patent. In 

enacting the Drug Price Competition 

and Patent Term Restoration Act of 1984 

and the Animal Drug and Patent Term 

Restoration Act of 1988, Congress 

sought to encourage development of 

new, safer, and more effective medical 

and food additive products. It did so by 

authorizing the U.S. Patent and 

Trademark Office (PTO) to extend the 

patent term by a portion of the time 

during which FDA’s safety and 

mstockstill on DSKH9S0YB1PROD with NOTICES

61494 Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices 

effectiveness review prevented 

marketing of the product. The length of 

the patent term extension is generally 

limited to a maximum of 5 years, and 

is calculated by PTO based on a 

statutory formula. When a patent holder 

submits an application for patent term 

extension to PTO, PTO requests 

information from FDA, including the 

length of the regulatory review period 

for the patented product. If PTO 

concludes that the product is eligible for 

patent term extension, FDA publishes a 

notice that describes the length of the 

regulatory review period and the dates 

used to calculate that period. Interested 

parties may request, under § 60.24 (21 

CFR 60.24), revision of the length of the 

regulatory review period, or may 

petition under § 60.30 (21 CFR 60.30) to 

reduce the regulatory review period by 

any time where marketing approval was 

not pursued with ‘‘due diligence.’’ The 

statute defines due diligence as ‘‘that 

degree of attention, continuous directed 

effort, and timeliness as may reasonably 

be expected from, and are ordinarily 

exercised by, a person during a 

regulatory review period.’’ As provided 

in § 60.30(c), a due diligence petition 

‘‘shall set forth sufficient facts, including 

dates if possible, to merit an 

investigation by FDA of whether the 

applicant acted with due diligence.’’ 

Upon receipt of a due diligence petition, 

FDA reviews the petition and evaluates 

whether any change in the regulatory 

review period is necessary. If so, the 

corrected regulatory review period is 

published in the Federal Register. A 

due diligence petitioner not satisfied 

with FDA’s decision regarding the 

petition may, under § 60.40 (21 CFR 

60.40), request an informal hearing for 

reconsideration of the due diligence 

determination. Petitioners are likely to 

include persons or organizations having 

knowledge that FDA’s marketing 

permission for that product was not 

actively pursued throughout the 

regulatory review period. The 

information collection for which an 

extension of approval is being sought is 

the use of the statutorily created due 

diligence petition. 

Since 1992, 12 requests for revision of 

the regulatory review period have been 

submitted under § 60.24. For 2007, 

2008, and 2009, a total of three, or one 

per year, have been submitted under 

§ 60.24. Two regulatory review periods 

have been altered. During that same 

time period, two due diligence petitions 

were submitted to FDA under § 60.30, 

for an average of fewer than one per 

year. There have been no requests for 

hearings under § 60.40 regarding the 

decisions on such petitions; however, 

for purposes of this information 

collection approval, we are estimating 

that we may receive one submission 

annually. 

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 

60.24(a) 1 100 1 100 100 

60.30 1 50 1 50 50 

60.40 1 100 1 10 10 

Total 160 

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

Dated: September 30, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–25010 Filed 10–4–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0492] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medical Devices: 

Recommended Glossary and 

Educational Outreach to Support Use 

of Symbols on Labels and in Labeling 

of In Vitro Diagnostic Devices Intended 

for Professional Use 

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, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the reporting requirements for the 

collection ‘‘Recommended Glossary and 

Educational Outreach to Support Use of 

Symbols on Labels and in Labeling of In 

Vitro Diagnostic Devices Intended for 

Professional Use.’’ 

DATES: Submit written or electronic 

comments on the collection of 

information by December 6, 2010. 

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: 

Daniel Gittleson, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

5156, Daniel.Gittleson@fda.hhs.gov. 

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, 

including each proposed extension of an 

mstockstill on DSKH9S0YB1PROD with NOTICES