Federal Register / Vol. 76, No. 52 / Thursday, March 17, 2011 / Notices 14671 

collaboration with the Health Resources 

and Services Administration, Maternal 

and Child Health Bureau, recently 

awarded grants for the Tribal Maternal, 

Infant, and Early Childhood Home 

Visiting Program (Tribal Home Visiting). 

The Tribal Home Visiting grant awards 

will support 5-year cooperative 

agreements to conduct community 

needs assessments, plan for and 

implement high-quality, culturallyrelevant, evidence-based home visiting 

programs in at-risk Tribal communities, 

and participate in research and 

evaluation activities to build the 

knowledge base on home visiting among 

Native populations. 

In Phase 1 (Year 1) of the cooperative 

agreement, grantees must (1) conduct a 

comprehensive community needs 

assessment and (2) develop a plan and 

begin to build capacity to respond to 

identified needs. Grantees will be 

expected to submit the needs 

assessment and plan for responding to 

identified needs through an evidencebased home visiting program within 

10 months of the Year 1 award date. 

Grantees may engage in needs 

assessment, planning, and capacitybuilding activities during Phase 1, but 

will not fully implement their plan and/ 

or begin serving children and families 

through high-quality, evidence-based 

home visiting programs. Pending 

successful Phase 1 activities and 

submission (within 10 months of Year 1 

award date) of a non-competing 

continuation application that includes a 

needs assessment and approvable plan 

for responding to identified needs, 

funds will be provided for Phase 2 

(Implementation Phase, Years 2–5) 

Respondents: Affordable Care Act 

Tribal Maternal, Infant, andEarly 

Childhood Home Visiting Year 1 

Grantees. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

Needs Assessment and Plan .......................................................................... 18 1 100 1,800 

Estimated Total Annual Burden 

Hours: 1,800. 

Additional Information: 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. E-mail address: 

infocollection@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: 202–395–7285, 

E-mail: 

OIRA_SUBMISSION@OMB.EOP.GOV, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Robert Sargis, 

Reports Clearance Officer. 

[FR Doc. 2011–6068 Filed 3–16–11; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–E–0405] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; ISTODAX 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

ISTODAX 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 human drug product. 

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 (Pub. L. 98–417) 

and the Generic Animal Drug and Patent 

Term Restoration Act (Pub. L. 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 human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

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 ISTODAX 

(romidepsin). ISTODAX is indicated for 

treatment of cutaneous T-cell lymphoma 

in patients who have received at least 

one prior systemic therapy. Subsequent 


srobinson on DSKHWCL6B1PROD with NOTICES
14672 Federal Register / Vol. 76, No. 52 / Thursday, March 17, 2011 / Notices 

to this approval, the Patent and 

Trademark Office received a patent term 

restoration application for ISTODAX 

(U.S. Patent No. 4,977,138) from 

Gloucester Pharmaceuticals, 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 

September 30, 2010, FDA advised the 

Patent and Trademark Office that this 

human drug product had undergone a 

regulatory review period and that the 

approval of ISTODAX 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 

ISTODAX is 2,717 days. Of this time, 

2,419 days occurred during the testing 

phase of the regulatory review period, 

while 298 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: May 31, 

2002. The applicant claims April 30, 

2002, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was May 31, 2002, 

which was 30 days after FDA receipt of 

the 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: January 12, 

2009. FDA has verified the applicant’s 

claim that the new drug application 

(NDA) for ISTODAX (NDA 22–393) was 

initially submitted on January 12, 2009. 

3. The date the application was 

approved: November 5, 2009. FDA has 

verified the applicant’s claim that NDA 

22–393 was approved on November 5, 

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 1,523 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 May 16, 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 

September 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: February 14, 2011. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2011–6162 Filed 3–16–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; 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 Institute of 

General Medical Sciences Special Emphasis 

Panel; Eureka Applications. 

Date: April 7–8, 2011. 

Time: 9 a.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building, 45 Center Drive, Room 

3AN18, Bethesda, MD 20892 (Virtual 

Meeting). 

Contact Person: Lisa A. Dunbar, PhD, 

Scientific Review Officer, Office of Scientific 

Review, National Institute of General Medical 

Sciences, National Institutes of Health, 45 

Center Drive, Room 3AN12, Bethesda, MD 

20892, 301–594–2849, dunbarl@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.375, Minority Biomedical 

Research Support; 93.821, Cell Biology and 

Biophysics Research; 93.859, Pharmacology, 

Physiology, and Biological Chemistry 

Research; 93.862, Genetics and 

Developmental Biology Research; 93.88, 

Minority Access to Research Careers; 93.96, 

Special Minority Initiatives, National 

Institutes of Health, HHS) 

Dated: March 11, 2011. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2011–6262 Filed 3–16–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meetings 

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 meetings. 

The meetings 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 Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; PAR09–247 

Ancillary Clinical Studies: Nephropathy and 

Urinary Incontinence. 

Date: April 4, 2011. 

Time: 1 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892, (Telephone 

Conference Call). 

Contact Person: Ann A. Jerkins, PhD, 

Scientific Review Officer, Review Branch, 

DEA, NIDDK, National Institutes of Health, 

Room 759, 6707 Democracy Boulevard, 

Bethesda, MD 20892–5452, 301–594–2242, 

jerkinsa@niddk.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 


srobinson on DSKHWCL6B1PROD with NOTICES