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 

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Federal Register / Vol. 75, No. 192 / Tuesday, October 5, 2010 / Notices 61495 

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. 

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 

(OMB Control Number 0910–0553)— 

Extension 

Section 502 of the Federal Food, Drug 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 352), among other things, 

establishes requirements for the label or 

labeling of a medical device so that it is 

not misbranded. Section 351 of the 

Public Health Service Act (the PHS Act) 

(42 U.S.C. 262) establishes requirements 

that manufacturers of biological 

products must submit a license 

application for FDA review and 

approval prior to marketing a biological 

product for introduction into interstate 

commerce. 

In the Federal Register of November 

30, 2004 (69 FR 69606), FDA published 

a notice of availability of the guidance 

entitled ‘‘Use of Symbols on Labels and 

in Labeling of In Vitro Diagnostic 

Devices Intended for Professional Use.’’ 

The guidance document provides 

guidance for the voluntary use of 

selected symbols in place of text in 

labeling. It provides the labeling 

guidance required for: (1) In vitro 

diagnostic devices (IVDs), intended for 

professional use under 21 CFR 809.10, 

FDA’s labeling requirements for IVDs 

and (2) FDA’s labeling requirements for 

biologics, including IVDs under 21 CFR 

parts 610 and 660. Under section 502(c) 

of the FD&C Act, a drug or device is 

misbranded, ‘‘* * *If any word, 

statement, or other information required 

by or under authority of this Act to 

appear on the label or labeling is not 

prominently placed thereon with such 

conspicuousness (as compared with 

other words, statements, designs, or 

devices, in the labeling) and in such 

terms as to render it likely to be read 

and understood by the ordinary 

individual under customary conditions 

of purchase and use.’’ 

The guidance document recommends 

that a glossary of terms accompany each 

IVD to define the symbols used on that 

device’s labels and/or labeling. 

Furthermore, the guidance recommends 

an educational outreach effort to 

enhance the understanding of newly 

introduced symbols. Both the glossary 

and educational outreach information 

will help to ensure that IVD users will 

have enough general familiarity with the 

symbols used, as well as provide a quick 

reference for available materials, thereby 

further ensuring that such labeling 

satisfies the labeling requirements under 

section 502(c) of the FD&C Act and 

section 351 of the PHS Act. 

The likely respondents for this 

collection of information are IVD 

manufacturers who plan to use the 

selected symbols in place of text on the 

labels and/or labeling of their IVDs. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

Section 502 of the FD&C 

Act/Section 351 of the PHS 

Act 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Glossary 689 1 689 4 2,756 

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

The glossary activity is inclusive of 

both domestic and foreign IVD 

manufacturers. FDA receives 

submissions from approximately 689 

IVD manufacturers annually. The 

number of hours per response for the 

glossary and educational outreach 

activities were derived from 

consultation with a trade association 

and FDA personnel. The 4-hour 

estimate for a glossary is based on the 

average time necessary for a 

manufacturer to modify the glossary for 

the specific symbols used in labels or 

labeling for the IVDs manufactured. 

Dated: September 30, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–25008 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–0161] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Export of Food and 

Drug Administration Regulated 

Products: Export Certificates 

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 November 

4, 2010. 

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: 

202–395–7285, or emailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0498. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

mstockstill on DSKH9S0YB1PROD with NOTICES