77880 Federal Register / Vol. 75, No. 239 / Tuesday, December 14, 2010 / Notices 

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 SAMSCA 

(tolvaptan). SAMSCA is indicated for 

the treatment of clinically significant 

hypervolemic and euvolemic 

hyponatremia, including patients with 

heart failure, cirrhosis, and Syndrome of 

Inappropriate Antidiuretic Hormone. 

Subsequent to this approval, the Patent 

and Trademark Office received patent 

term restoration applications for 

SAMSCA (U.S. Patent Nos. 5,258,510 

and 5,753,677) from Otsuka 

Pharmaceutical Co., Ltd., and the Patent 

and Trademark Office requested FDA’s 

assistance in determining these patents’ 

eligibility for patent term restoration. In 

a letter dated March 3, 2010, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period 

and that the approval of SAMSCA 

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 

SAMSCA is 4,722 days. Of this time, 

4,147 days occurred during the testing 

phase of the regulatory review period, 

while 575 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 FD&C Act) (21 

U.S.C. 355(i)) became effective: June 16, 

1996. The applicant claims October 23, 

1997, as the date the investigational new 

drug application (IND) became effective. 

However, according to FDA records, this 

IND was not the first IND received for 

this active ingredient. In general, FDA 

has used the first IND of the active 

ingredient of the drug product as the 

beginning of the testing phase, if 

information derived from this first IND 

was or could have been relied on or was 

relevant for approval to market the drug 

product. FDA records indicate that the 

effective date of the first IND for 

tolvaptan was June 16, 1996, which was 

30 days after FDA receipt of this first 

IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FD&C Act: October 23, 

2007. FDA has verified the applicant’s 

claim that the new drug application 

(NDA) for SAMSCA (NDA 22–275) was 

submitted on October 23, 2007. 

3. The date the application was 

approved: May 19, 2009. FDA has 

verified the applicant’s claim that NDA 

22–275 was approved on May 19, 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 applications for patent extension, 

this applicant seeks 1,826 days or 1,827 

days respectively 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 February 14, 

2011. 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 June 13, 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 

ADDRESSES) electronic or written 

comments and written petitions. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send three copies of mailed comments. 

However, if you submit a written 

petition, you must submit three copies 

of the petition. Identify comments with 

the docket number found in brackets in 

the heading of this document. 

Comments and petitions that have not 

been made publicly available on 

regulations.gov may be viewed in the 

Division of Dockets Management 

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

through Friday. 

Dated: October 22, 2010. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2010–31298 Filed 12–13–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; Comment 

Request; GuLF Worker Study: Gulf 

Long-Term Follow-Up Study for Oil 

Spill Clean-Up Workers and Volunteers 

SUMMARY: Under the provisions of 

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

Reduction Act of 1995, the National 

Institute of Environmental Health 

Sciences (NIEHS), the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. This proposed information 

collection was previously published in 

the Federal Register on 7 October 2010 

on pages 62132–3 and allowed 60-days 

for public comment. One public 

comment was received and addressed 

regarding the appropriateness and 

sources for funding the survey. 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. 

5 CFR 1320.5: Reporting and 

Recordkeeping Requirements: Final 

Rule: Respondents to this collection of 

information are not required to respond 

unless the data collection instruments 

display a currently valid OMB control 

number. 

Proposed Collection 

Title: GuLF Worker Study: Gulf LongTerm Follow-Up Study for Oil Spill 

Clean-Up Workers and Volunteers. Type 

of Information Collection Request: New. 

Need and Use of Information Collection: 

The purpose of the GuLF Study is to 

investigate potential short- and longterm health effects associated with oil 

spill clean-up activities and exposures 

surrounding the Deepwater Horizon 

disaster; and to create a resource for 

additional collaborative research on 

focused hypotheses or subgroups. Over 

55,000 persons participating in oil-spill 

clean-up activities have been exposed to 

a range of known and suspected toxins 

in crude oil, burning oil, and 

dispersants, to excessive heat, and 

possibly to stress due to widespread 

economic and lifestyle disruption. 

Exposures range from negligible to 

potentially significant, however, 

potential long-term human health 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 239 / Tuesday, December 14, 2010 / Notices 77881 

consequences are largely unknown due 

to insufficient research in this area. 

Participants will be recruited from 

across job/exposure groups of primarily 

English, Spanish, or Vietnamese 

speaking adults (accommodations for 

other languages developed as 

appropriate) who performed oil-spill 

clean-up-related work (‘‘exposed’’) and 

similar persons who did not 

(‘‘unexposed’’ controls), and followed in 

either an Active Follow-up Cohort 

(N∼27,000) or a Passive Follow-up 

Cohort (N∼28,000). Exposures will be 

estimated using detailed job-exposure 

matrices developed from data from 

monitoring performed by different 

agencies and organizations during the 

crisis, information obtained by 

interview, and the available scientific 

literature. We will investigate acute 

health effects among all cohort members 

via self-report from the enrollment 

interview, and via clinical measures and 

biological samples from Active Followup Cohort members only. All cohort 

members will be followed for 

development of a range of health 

outcomes through record linkage (e.g., 

cancer, mortality) and possibly through 

linkage with routinely collected health 

surveillance data (collected by health 

departments and the CDC) or with 

electronic medical records. Recruitment 

of subjects should begin in late 2010, 

with telephone interviews and the 

baseline home visits conducted within 

18 months. 

Activity (3-yrs) 

Estimated 

number of 

respondents 

Estimated 

responses per 

respondent 

Burden hours 

per response 

Total burden 

hours per 

respondent 

Estimated 

total burden 

hours 

Ineligible respondents .......................................................... 25,000 1 0.25 0.25 6,250 

Enrollment interview (All) ..................................................... 55,000 1 0.50 0.50 27,500 

Home Visit (Active) .............................................................. 27,000 1 2.75 2.75 74,250 

Annual Contact Info Update (Passive) ................................ 28,000 3 0.25 0.75 21,000 

Annual Contact Info Update (Active) ................................... 27,000 2 0.25 0.50 13,500 

Biennial interview (Active) .................................................... 27,000 1 0.50 0.50 13,500 

Passive Cohort Total responses & hrs ......................... ........................ 4 ........................ 1.25 ........................

Active Cohort Total responses & hrs ........................... ........................ 5 ........................ 4.25 ........................

TOTAL responses & avg hrs per response .......... ........................ 9 ........................ 0.58 156,000 

Average per year ............................................ ........................ ........................ ........................ ........................ 52,000 

Frequency of Response: Participation 

will include one enrollment telephone 

interview (0.5 hr); collection of 

biological and environmental samples, 

basic clinical measurements, and GPS 

coordinates (2.75 hr) from the Active 

Follow-up Cohort only; annual contact 

information update (0.25; Active and 

Passive) or biennial follow-up telephone 

or Web interviews (0.5 hr; Active only) 

for 10 years or more. We also anticipate 

screening 25,000 ineligible respondents. 

Affected Public: Individuals or 

households. Type of Respondents: 

Workers involved in Deepwater Horizon 

disaster clean-up, and similar 

individuals not involved in clean-up 

effort. The annual reporting burden is as 

follows: Estimated Number of 

Respondents: Active Follow-up Cohort 

(N∼27,000) and Passive Follow-up 

Cohort (N∼28,000). 

Estimated Number of Responses per 

Respondent: See table. 

Average Burden Hours Per Response: 

0.58 hour; and Estimated Total Burden 

Hours Requested: 156,000 (over 3 years). 

The average annual burden hours 

requested is 52,000. The annualized cost 

to respondents is estimated at $11.60 

(assuming $20 hourly wage × 0.58 hour). 

There are no Capital Costs to report. 

There are no Operating or Maintenance 

Costs to report. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) 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) 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) 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 those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

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 project or to obtain 

a copy of the data collection plans and 

instruments, contact: Dr. Dale P. 

Sandler, Chief, Epidemiology Branch, 

NIEHS, Rall Building A3–05, PO Box 

12233, Research Triangle Park, NC 

27709; non-toll-free number 919–541– 

4668 or e-mail sandler@niehs.nih.gov. 

Include your address. 

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: December 9, 2010. 

W. Christopher Long, 

NIEHS, Acting Associate Director for 

Management, National Institutes of Health. 

[FR Doc. 2010–31377 Filed 12–13–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; Recruitment and 

Screening for the Insight Into 

Determination of Exceptional Aging 

and Longevity (IDEAL) Study 

SUMMARY: Under the provisions of 

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

Reduction Act of 1995, the National 

Institute on Aging (NIA), the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. This proposed information 

collection was previously published in 

the Federal Register on September 17, 

2010, page 57038 and allowed 60-days 

for public comment. No public 

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 


srobinson on DSKHWCL6B1PROD with NOTICES