Federal Register / Vol. 76, No. 8 / Wednesday, January 12, 2011 / Notices 2127 

will submit one Form FDA 3519 for a 

total of 500 annual responses. Each 

submission is estimated to take 0.1 hour 

per response for a total of 50 hours. FDA 

estimates that, annually, 500 regulatory 

jurisdictions will submit one Form FDA 

3520 for a total of 500 annual responses. 

Each of these submissions is estimated 

to take 0.1 hour per response for a total 

of 50 hours. FDA estimates that, 

annually, 500 regulatory jurisdictions 

will submit three requests for 

documentation of successful completion 

of staff training using the CFP Training 

Plan and Log for a total of 1,500 annual 

responses. Each submission is estimated 

to take 0.1 hour per response for a total 

of 150 hours. Thus, the total reporting 

burden for this information collection is 

250 hours. 

Dated: January 5, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–458 Filed 1–11–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0468] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

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 

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 February 

11, 2011. 

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 e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0233. Also 

include the FDA 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., 

PI50–400B, Rockville, MD 20850, 301– 

796–3792, 

Elizabeth.Berbakos@fda.hhs.gov. 

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. Patent Term 

Restoration, Due Diligence Petitions, 

Filing, Format, and Content of 

Petitions—(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 the 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 

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. 

In the Federal Register of October 5, 

2010 (75 FR 61493), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received on the information collection. 

FDA estimates the burden of this 

collection of information as follows: 

mstockstill on DSKH9S0YB1PROD with NOTICES

2128 Federal Register / Vol. 76, No. 8 / Wednesday, January 12, 2011 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR section Number of 

respondents 

Annual 

frequency 

per 

response 

Total annual 

responses 

Hours per 

response Total hours 

60.24(a) ................................................................................ 1 1 1 100 100 

60.30 .................................................................................... 1 1 1 50 50 

60.40 .................................................................................... 1 1 1 10 10 

Total .............................................................................. ........................ ........................ ........................ ........................ 160 

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

Dated: January 5, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–459 Filed 1–11–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel, 

Loan Repayment Program Review. 

Date: February 1, 2011. 

Time: 8 a.m. to 11 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

(Virtual Meeting.) 

Contact Person: Tony L Creazzo, PhD, 

Scientific Review Officer, Office of Scientific 

Review/DERA, National Heart, Lung, and 

Blood Institute, 6701 Rockledge Drive, Room 

7180, Bethesda, MD 20892–7924. 301–435– 

0725. creazzotl@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: January 6, 2011. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–583 Filed 1–11–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Alcohol Abuse 

and Alcoholism; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable materials, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Alcohol Abuse and Alcoholism Initial 

Review Group. Epidemiology, Prevention 

and Behavior Research Review 

Subcommittee. 

Date: March 29–30, 2011. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Ranga V. Srinivas, PhD, 

Scientific Review Officer, National Institute 

on Alcohol Abuse and Alcoholism, 

Extramural Project Review Branch, 5635 

Fishers Lane, Room 2085, Bethesda, MD 

20892. 301–451–2067. srinivar@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.271, Alcohol Research 

Career Development Awards for Scientists 

and Clinicians; 93.272, Alcohol National 

Research Service Awards for Research 

Training; 93.273, Alcohol Research Programs; 

93.891, Alcohol Research Center Grants; 

93.701, ARRA Related Biomedical Research 

and Research Support Awards, National 

Institutes of Health, HHS) 

Dated: January 6, 2011. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–582 Filed 1–11–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Microbiology, 

Infectious Diseases and AIDS Initial Review 

Group. Microbiology and Infectious Diseases 

B Subcommittee. 

Date: February 10–11, 2011. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Courtyard by Marriott, 5520 

Wisconsin Avenue, Chevy Chase, MD 20815. 

Contact Person: Gary S. Madonna, PhD, 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

NIAID, National Institutes of Health, 6700B 

Rockledge Drive, MSC 7616, Bethesda, MD 

20892. 301–496–3528. gm12w@nih.gov. 

mstockstill on DSKH9S0YB1PROD with NOTICES