Federal Register / Vol. 80, No. 22 / Tuesday, February 3, 2015 / Notices 5763 

than the risk of using the reference 

product without such alternation or 

switch. 

In addition to the collection of 

information regarding the submission of 

a 351(k) application for a proposed 

biosimilar or interchangeable biological 

product, section 351(l) of the BPCI Act 

establishes procedures for identifying 

and resolving patent disputes involving 

applications submitted under section 

351(k) of the PHS Act. The burden 

estimates for the patent provisions 

under section 351(l)(6)(C) of the BPCI 

Act are included in table 1 of this 

document and are based on the 

estimated number of 351(k) biosimilar 

respondents. Based on similar reporting 

requirements, FDA estimates this 

notification will take 2 hours. A 

summary of the collection of 

information requirements under section 

351(l)(6)(C) follows: 

Not later than 30 days after a 

complaint from the reference product 

sponsor is served to a 351(k) applicant 

in an action for patent infringement 

described under 351(l)(6), section 

351(l)(6)(C) requires that the 351(k) 

applicant provide the Secretary with 

notice and a copy of such complaint. 

The Secretary shall publish in the 

Federal Register notice any complaint 

received under section 351(l)(6)(C)(i). 

Based on the number of 351(k) 

applications FDA received through FY 

2014, we estimate that we will receive 

approximately five 351(k) applications 

annually. The number of respondents 

submitting 351(k) applications is based 

on the number of sponsors submitting 

351(k) applications through FY 2014. In 

making these estimates, FDA has taken 

into account, among other things, the 

expiration dates of patents that relate to 

potential reference products, and 

general market interest in biological 

products that could be candidates for 

351(k) applications. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

351(k) Applications (42 U.S.C. 262(k)) Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

351(k)(2)(A)(i) and 351(k)(2)(A)(iii) Biosimilar Product Applications ........................................................................... 5 1 5 860 4,300 

351(k)(2)(B) and (k)(4) Interchangeable Product Applications or Supplements ....................................................... 2 1 2 860 1,720 

351(l)(6)(C) Patent Infringement Notifications ..................... 5 1 5 2 10 

Total .............................................................................. ........................ ........................ ........................ ........................ 6,030 

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

Dated: January 28, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–02025 Filed 2–2–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

Charter Renewal 

In accordance with Title 41 of the 

U.S. Code of Federal Regulations, 

Section 102–3.65(a), notice is hereby 

given that the Charter for the National 

Cancer Institute Council of Research 

Advocates (formerly known as the 

National Cancer Institute Director’s 

Consumer Liaison Group) was renewed 

for an additional two-year period on 

August 17, 2014. 

It is determined that the National 

Cancer Institute Council of Research 

Advocates is in the public interest in 

connection with the performance of 

duties imposed on the National 

Institutes of Health by law, and that 

these duties can best be performed 

through the advice and counsel of this 

group. 

Inquiries may be directed to Jennifer 

Spaeth, Director, Office of Federal 

Advisory Committee Policy, Office of 

the Director, National Institutes of 

Health, 6701 Democracy Boulevard, 

Suite 1000, Bethesda, Maryland 20892 

(Mail Stop Code 4875), Telephone (301) 

496–2123, or spaethj@od.nih.gov. 

Dated: January 28, 2015. 

Melanie J. Gray, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2015–01976 Filed 2–2–15; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health 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 

Environmental Health Sciences Special 

Emphasis Panel; Review of Superfund 

Hazardous Research and Training Programs. 

Date: February 25–27, 2015. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Sheraton Chapel Hill Hotel, One 

Europa Drive, Chapel Hill, NC 27514. 

Contact Person: Leroy Worth, Ph.D., 

Scientific Review Officer, Scientific Review 

Branch, Division of Extramural Research and 

Training, Nat. Institute of Environmental 

Health Sciences, P.O. Box 12233, MD EC–30/ 

Room 3171, Research Triangle Park, NC 

27709, (919) 541–0670, worth@niehs.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.115, Biometry and Risk 

Estimation—Health Risks from 

Environmental Exposures; 93.142, NIEHS 

Hazardous Waste Worker Health and Safety 

Training; 93.143, NIEHS Superfund 

Hazardous Substances—Basic Research and 

Education; 93.894, Resources and Manpower 

Development in the Environmental Health 

Sciences; 93.113, Biological Response to 

Environmental Health Hazards; 93.114, 

Applied Toxicological Research and Testing, 

National Institutes of Health, HHS) 


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