Federal Register / Vol. 80, No. 22 / Tuesday, February 3, 2015 / Notices 5761 

screened and selected from Individuals 

and Households, Businesses, 

Organizations, and/or State, Local or 

Tribal Government. There is no cost to 

respondents other than their time. The 

estimated total burden hours for this 

data collection activity are 268. 

Type of collection 

Average 

number of 

respondents 

per activity 

Annual 

frequency 

per response 

Average 

number of 

activities 

Average hours 

per response 

Online surveys, Telephone Surveys, Focus Groups, In person observation/

testing ........................................................................................................... 67 1 5 48/60 

Leroy A. Richardson, 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2015–02062 Filed 2–2–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Board of Scientific Counselors, 

National Center for Environmental 

Health/Agency for Toxic Substances 

and Disease Registry: Notice of 

Charter Renewal 

This gives notice under the Federal 

Advisory Committee Act (Pub. L. 92– 

463) of October 6, 1972, that the Board 

of Scientific Counselors, National 

Center for Environmental Health/

Agency for Toxic Substances and 

Disease Registry, Department of Health 

and Human Services, has been renewed 

for a 2-year period through May 21, 

2016. 

For information, contact William 

Cibulas, Ph.D., Designated Federal 

Officer, Board of Scientific Counselors, 

National Center for Environmental 

Health/Agency for Toxic Substances 

and Disease Registry, Department of 

Health and Human Services, 4770 

Buford Highway, Mailstop F61, 

Chamblee, Georgia 30341, telephone 

(770) 488–0662 or fax (770) 488–3385. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2015–02026 Filed 2–2–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0129] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; General Licensing 

Provisions; Section 351(k) Biosimilar 

Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the information collection in an 

application for a proposed biosimilar 

product and an application for a 

supplement for a proposed 

interchangeable product. 

DATES: Submit either electronic or 

written comments on the collection of 

information by April 6, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA 305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’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 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

General Licensing Provisions; Section 

351(k) Biosimilar Applications (OMB 

Control Number 0910–0719)—Extension 

The Patient Protection and Affordable 

Care Act (Affordable Care Act) (Pub. L. 

111–148) contains a subtitle called the 

Biologics Price Competition and 

Innovation Act of 2009 (BPCI Act), 

which amends the Public Health Service 

Act (PHS Act) and establishes an 

abbreviated licensure pathway for 


rljohnson on DSK3VPTVN1PROD with NOTICES
5762 Federal Register / Vol. 80, No. 22 / Tuesday, February 3, 2015 / Notices 

biological products shown to be 

biosimilar to, or interchangeable with, 

an FDA-licensed biological reference 

product (See sections 7001 through 

7003 of the Affordable Care Act.) 

Section 351(k) of the PHS Act (42 

U.S.C. 262(k)), added by the BPCI Act, 

sets forth the requirements for an 

application for a proposed biosimilar 

product and an application or a 

supplement for a proposed 

interchangeable product. Section 351(k) 

defines biosimilarity to mean ‘‘that the 

biological product is highly similar to 

the reference product notwithstanding 

minor differences in clinically inactive 

components’’ and that ‘‘there are no 

clinically meaningful differences 

between the biological product and the 

reference product in terms of the safety, 

purity, and potency of the product.’’ 

(See section 351(i)(2) of the PHS Act.) A 

351(k) application must contain, among 

other things, information demonstrating 

that the biological product is biosimilar 

to a reference product based upon data 

derived from analytical studies, animal 

studies, and clinical studies, unless 

FDA determines, in its discretion, that 

certain studies are unnecessary in a 

351(k) application. (See section 

351(k)(2) of the PHS Act.) To 

demonstrate interchangeability, an 

applicant must provide sufficient 

information to demonstrate 

biosimilarity and that the biosimilar 

biological product can be expected to 

produce the same clinical result as the 

reference product in any given patient 

and, if the biosimilar biological product 

is administered more than once to an 

individual, the risk in terms of safety or 

diminished efficacy of alternating or 

switching between the use of the 

biosimilar biological product and the 

reference product is not greater than the 

risk of using the reference product 

without such alternation or switch. (See 

section 351(k)(4) of the PHS Act.) 

Interchangeable products may be 

substituted for the reference product 

without the intervention of the 

prescribing health care provider. (See 

section 351(i)(3) of the PHS Act.) 

In estimating the information 

collection burden for 351(k) 

applications, we reviewed the number 

of 351(k) applications FDA has received 

through fiscal year (FY) 2014, as well as 

the collection of information regarding 

the general licensing provisions for 

biologics license applications under 

section 351(a) of the PHS Act submitted 

to OMB (approved under OMB control 

number 0910–0338). For the 

information collection burden for 351(a) 

applications, FDA described § 601.2(a) 

(21 CFR 601.2(a)) as requiring a 

manufacturer of a biological product to 

submit an application on forms 

prescribed for such purpose with 

accompanying data and information 

including certain labeling information 

to FDA for approval to market a product 

in interstate commerce. FDA also added 

in the burden estimate the container and 

package labeling requirements provided 

under §§ 610.60 through 610.65 (21 CFR 

610.60 through 610.65). The estimated 

hours per response for § 601.2, and 

§§ 610.60 through 610.65, are 860 hours. 

In addition, in submitting a 351(a) 

application, an applicant completes the 

Form FDA 356h ‘‘Application to Market 

a New Drug, Biologic, or an Antibiotic 

Drug for Human Use.’’ The application 

form serves primarily as a checklist for 

firms to gather and submit certain 

information to FDA. The checklist helps 

to ensure that the application is 

complete and contains all the necessary 

information, so that delays due to lack 

of information may be eliminated. The 

form provides key information to FDA 

for efficient handling and distribution to 

the appropriate staff for review. The 

estimated burden hours for biological 

product submissions using FDA Form 

356h are included under the applicable 

requirements approved under OMB 

control number 0910–0338. 

To submit an application seeking 

licensure of a proposed biosimilar 

product under section 351(k)(2)(A)(i) 

and (k)(2)(A)(iii) of the PHS Act, FDA 

believes that the estimated burden hours 

would be approximately the same as 

noted under OMB control number 

0910–0338 for a 351(a) application—860 

hours. The burden estimates for seeking 

licensure of a proposed biosimilar 

product that meets the standards for 

interchangeability under section 

351(k)(2)(B) and (k)(4) would also be 

860 hours. Until we gain more 

experience with biosimilar applications, 

FDA believes this estimate is 

appropriate for 351(k) applications 

because to determine biosimilarity or 

interchangeability of a proposed 351(k) 

product, the application and the 

information submitted is expected to be 

comparably complex and technically 

demanding as a proposed 351(a) 

application. FDA may determine, in its 

discretion, an element required under a 

351(k) application to be unnecessary to 

support licensure of a biosimilar or 

interchangeable product. In those cases, 

the number of hours per response may 

be less than the hours estimated. 

A summary of the information 

collection requirements in the 

submission of a 351(k) application as 

described under the BPCI Act follows: 

Section 351(k)(2)(A)(i) requires 

manufactures of 351(k) products to 

submit an application for FDA review 

and licensure before marketing a 

biosimilar product. An application 

submitted under this section shall 

include information demonstrating that: 

• The biological product is biosimilar 

to a reference product based upon data 

derived from analytical studies, animal 

studies (including toxicity) and a 

clinical study or studies (including 

immunogenicity and pharmacokinetics 

or pharmacodynamics). The Secretary of 

Health and Human Services (the 

Secretary) may determine that any of 

these elements is unnecessary. 

• The biological product and 

reference product utilize the same 

mechanism or mechanisms of action for 

the condition or conditions of use 

prescribed, recommended, or suggested 

in the proposed labeling, but only to the 

extent the mechanism or mechanisms of 

action are known for the reference 

product. 

• The condition or conditions of use 

prescribed, recommended, or suggested 

in the labeling proposed for the 

biological product have been previously 

approved for the reference product. 

• The route of administration, the 

dosage form, and the strength of the 

biological product are the same as those 

of the reference product. 

• The facility in which the biological 

product is manufactured, processed, 

packed, or held meets standards 

designed to assure that the biological 

product continues to be safe, pure, and 

potent. 

Section 351(k)(2)(A)(iii) requires the 

application to include publicly available 

information regarding the Secretary’s 

previous determination that the 

reference product is safe, pure, and 

potent. The application may include 

any additional information in support of 

the application, including publicly 

available information with respect to the 

reference product or another biological 

product. 

Under section 351(k)(2)(B) and (k)(4), 

a manufacturer may include information 

demonstrating that the biological 

product meets the standards for 

interchangeability either in the 

application to show biosimilarity or in 

a supplement to such an application. 

The information submitted to meet the 

standard for interchangeability must 

show that: (1) The biological product is 

biosimilar to the reference product and 

can be expected to produce the same 

clinical result as the reference product 

in any given patient; and (2) for a 

biological product that is administered 

more than once to an individual, the 

risk in terms of safety or diminished 

efficacy of alternating or switching 

between use of the biological product 

and the reference product is not greater 


rljohnson on DSK3VPTVN1PROD with NOTICES
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) 


rljohnson on DSK3VPTVN1PROD with NOTICES