54886 Federal Register / Vol. 75, No. 174 / Thursday, September 9, 2010 / Notices 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours per 

response 

Total burden 

hours 

Discussion Guide for Use with Researchers, Policy Experts, and 

State-level Coordinators ............................................................... 50 1 1 50 

Discussion Guide for Use with Program Directors .......................... 25 1 2.5 63 

Discussion Guide for Use with Program Staff ................................. 50 1 2 100 

Estimated Total Annual Burden Hours ..................................... 213 

Additional Information 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Planning, Research 

and Evaluation, 370 L’Enfant 

Promenade, SW., Washington, DC 

20447, Attn: OPRE Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. E-mail address: 

OPREinfocollection@acf.hhs.gov. 

OMB Comment 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: 

Office of Management and Budget, 

Paperwork Reduction Project, Fax: 202– 

395–6974,Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: September 1, 2010. 

Steven M. Hammer, 

OPRE Reports Clearance Officer. 

[FR Doc. 2010–22317 Filed 9–8–10; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; the Framingham 

Heart Study (FHS) 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the National 

Heart, Lung, and Blood Institute 

(NHLBI), the National Institutes of 

Health (NIH) has submitted to the Office 

of Management and Budget (OMB) a 

request for review and approval the 

information collection listed below. 

This proposed information collection 

was previously published in the Federal 

Register on May 10, 2010, pages 25863– 

4, and allowed 60-days for public 

comment. No comments were received. 

The purpose of this notice is to allow an 

additional 30 days for public comment. 

The National Institutes of Health may 

not conduct or sponsor, and the 

respondent is not required to respond 

to, an information collection that has 

been extended, revised, or implemented 

on or after October 1, 1995, unless it 

displays a currently valid OMB control 

number. 

Proposed Collection: Title: The 

Framingham Heart Study. Type of 

Information Request: Revision (OMB 

No. 0925–0216). Need and Use of 

Information Collection: The 

Framingham Heart Study will conduct 

examinations and morbidity and 

mortality follow-up for the purpose of 

studying the determinants of 

cardiovascular disease. Examinations 

will be conducted on the original, 

offspring, and Omni Cohorts. Morbidity 

and mortality follow-up will also occur 

in all of the cohorts (original, offspring, 

third generation, and Omni). Frequency 

of response: The participants will be 

contacted annually. Affected public: 

Individuals or households; businesses 

or other for profit; small businesses or 

organizations. Types of Respondents: 

Adult men and women; doctors and 

staff of hospitals and nursing homes. 

The annual reporting burden is as 

follows: Estimated Number of 

Respondents: 6,921; Estimated Number 

of Responses per Respondent: 1; 

Average Burden Hours Per Response: 

.88; and Estimated Total Annual Burden 

Hours Requested: 6,091. The annualized 

cost to respondents is estimated at: 

$222,040. There are no Capital Costs to 

report. There are no Operating or 

Maintenance Costs to report. 

Type of 

respondents 

Estimated 

number of 

respondents 

Estimated 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Estimated 

total annual 

burden hours 

requested 

Individuals (Participants and Informants) ........................................................ 4461 1 1.00 4442 

Physicians ........................................................................................................ 2460 1 0.67 1649 

Totals ........................................................................................................ 6921 ........................ ........................ 6091 

(Note: Reported and calculated numbers differ slightly due to rounding.) 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

address one or more of the following 

points: (1) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) Evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Minimize the burden 

of the collection of information on those 

who are to respond, including the use 

of appropriate automated, electronic, 

mechanical, or other technological 

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Federal Register / Vol. 75, No. 174 / Thursday, September 9, 2010 / Notices 54887 

collection techniques or other forms of 

information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, OIRA_

submission@omb.eop.gov or by fax to 

202–395–6974, Attention: Desk Officer 

for NIH. To request more information on 

the proposed project or to obtain a copy 

of the data collection plans and 

instruments, contact: Dr. Gina Wei, 

Division of Cardiovascular Sciences, 

NHLBI, NIH, Two Rockledge Center, 

6701 Rockledge Drive, MSC 7936, 

Bethesda, MD, 20892–7936, or call nontoll-free number (301) 435–0456, or email your request, including your 

address to: weig@nhlbi.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30-days of the date of 

this publication. 

Dated: September 1, 2010. 

Suzanne Freeman, 

NHLBI Project Clearance Liaison, National 

Institutes of Health. 

Michael Lauer, 

Director, DCVS, National Institutes of Health. 

[FR Doc. 2010–22472 Filed 9–8–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–E–0414] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; REPEL–CV 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for REPEL– 

CV 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 

medical device. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

petitions along with three copies and 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

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 medical devices, 

the testing phase begins with a clinical 

investigation of the device and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the device and continues until 

permission to market the device is 

granted. 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 (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 medical device will include 

all of the testing phase and approval 

phase as specified in 35 U.S.C. 

156(g)(3)(B). 

FDA recently approved for marketing 

the medical device, REPEL–CV. REPEL– 

CV, a bioresorbable adhesion barrier, is 

indicated for reducing the severity of 

post-operative cardiac adhesions in 

pediatric patients who are likely to 

require reoperation via sternotomy. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for REPEL– 

CV (U.S. Patent No. 5,711,958) from 

SyntheMed, Inc., and the Patent and 

Trademark Office requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated February 17, 2010, FDA 

advised the Patent and Trademark 

Office that this medical device had 

undergone a regulatory review period 

and that the approval of REPEL–CV 

represented the first permitted 

commercial marketing or use of the 

product. Thereafter, the Patent and 

Trademark Office requested that the 

FDA determine the product’s regulatory 

review period. 

FDA has determined that the 

applicable regulatory review period for 

REPEL–CV is 4,023 days. Of this time, 

3,256 days occurred during the testing 

phase of the regulatory review period, 

while 767 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 520(g) of the Federal Food, Drug, 

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

360j(g)) involving this device became 

effective: March 3, 1998. FDA has 

verified the applicant’s claim that the 

date the investigational device 

exemption (IDE) required under section 

520(g) of the act for human tests to begin 

became effective March 3, 1998. 

2. The date an application was 

initially submitted with respect to the 

device under section 515 of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

360e): January 30, 2007. FDA has 

verified the applicant’s claim that the 

premarket approval application (PMA) 

for REPEL–CV (PMA P070005) was 

initially submitted January 30, 2007. 

3. The date the application was 

approved: March 6, 2009. FDA has 

verified the applicant’s claim that PMA 

P070005 was approved on March 6, 

2009. 

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 1,742 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) either 

electronic or written comments and ask 

for a redetermination by November 8, 

2010. 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 March 8, 2011. 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. 

Interested persons may submit to the 

Division of Dockets Management (see 

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