Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Notices 12853 

only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

III. The Paperwork Reduction Act of 

1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520) and have been 

approved under OMB Control Numbers 

0910–0014 and 0910–0001. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or http:// 

www.regulations.gov. 

Dated: February 28, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–5069 Filed 3–1–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0618] 

Draft Guidances Relating to the 

Development of Biosimilar Products; 

Public Hearing; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearing; request 

for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

1-day public hearing to obtain input on 

recently issued draft guidances relating 

to the development of biosimilar 

products (draft guidances). These draft 

guidances were issued by FDA as part 

of the implementation of the Biologics 

Price Competition and Innovation Act of 

2009 (the BPCI Act). The BPCI Act 

establishes an abbreviated licensure 

pathway for biological products that are 

demonstrated to be biosimilar to, or 

interchangeable with, a reference 

product. FDA will consider the 

information it obtains from the public 

hearing in the finalization of these 

guidances. In addition, FDA is soliciting 

public input regarding topics for future 

policies regarding biosimilars. 

DATES: The public hearing will be held 

on May 11, 2012, from 8:30 a.m. to 5 

p.m. Individuals who wish to present at 

the public hearing must register by 

April 11, 2012. Section V of this 

document provides attendance and 

registration information. Electronic or 

written comments will be accepted after 

the public hearing until May 1, 2012. 

ADDRESSES: The public hearing will be 

held at FDA’s White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31, 

Rm. 1503, Silver Spring, MD 20993. 

Submit electronic comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. Identify 

comments with the corresponding 

docket number found in brackets in the 

heading of this document. 

Transcripts of the public hearing will 

be available for review at the Division 

of Dockets Management and on the 

Internet at http://www.regulations.gov 

approximately 30 days after the public 

hearing (see section VIII of this 

document). 

A live Web cast of this public hearing 

may be seen at http://www.fda.gov/

Drugs/NewsEvents/ucm265628.htm on 

the day of the public hearing. A video 

record of the public hearing will be 

available at the same Web address for 

1 year. 

FOR FURTHER INFORMATION CONTACT: 

Sandra J. Benton, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6340, 

Silver Spring, MD 20993, 301–796– 

1042, Fax: 301–847–3529, email: 

biosimilarspublicmtg@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On March 23, 2010, President Obama 

signed into law the Patient Protection 

and Affordable Care Act (Affordable 

Care Act) (Pub. L. 111–148). The 

Affordable Care Act contains the BPCI 

Act that amends the Public Health 

Service Act (the PHS Act) and other 

statutes to create an abbreviated 

licensure pathway for biological 

products shown to be biosimilar to, or 

interchangeable with, a reference 

product (see sections 7001 through 7003 

of the Affordable Care Act). 

The implementation of an abbreviated 

licensure pathway for biological 

products can present challenges given 

the scientific and technical complexities 

that may be associated with the larger 

and often more complex structure of 

biological products, as well as the 

processes by which such products are 

manufactured. Most biological products 

are produced in a living system such as 

a microorganism, or plant or animal 

cells, whereas small molecule drugs are 

typically manufactured through 

chemical synthesis. 

Among other things, 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 biological 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.’’ A 351(k) biosimilar 

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 a clinical study or studies, 

unless FDA determines that an element 

described here is unnecessary in a 

351(k) application. 

II. Previous Public Hearing on 

Biosimilar Pathway 

As part of our commitment to public 

outreach, FDA held a 2-day public 

hearing on the ‘‘Approval Pathway for 

Biosimilar and Interchangeable 

Biological Products’’ on November 2 

and 3, 2010 (75 FR 61497, October 5, 

2010) (November 2010 public hearing). 

The purpose of that public hearing was 

to seek comments on a number of issues 

relating to the implementation of the 

BPCI Act. Over 40 speakers presented at 

the public hearing. In addition to the 

presentations, FDA has received more 

than 60 public comments to the docket, 

which closed on December 31, 2010. 

Information on this prior public hearing, 

including the Federal Register notice, 

meeting transcripts, and public 

comments can be found at http:// 

www.regulations.gov (Docket No. FDA– 

2010–N–0477). FDA carefully 

considered the presentations and public 

comments as it was developing the 

recently issued draft guidances (see 

section III of this document). 

III. Draft Guidances 

FDA has issued the following three 

draft guidances as part of its initial 

implementation of the BPCI Act based 

on public input at the November 2010 

public hearing regarding priorities for 

issuing guidances: 


tkelley on DSK3SPTVN1PROD with NOTICES
12854 Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Notices 

1The Agency is not bound by this list of possible 

topics for future guidances. 

• Scientific Considerations in 

Demonstrating Biosimilarity to a 

Reference Product (scientific 

considerations draft guidance), 

• Questions and Answers Regarding 

Implementation of the Biologics Price 

Competition and Innovation Act of 2009 

(Q&A draft guidance), and 

• Quality Considerations in 

Demonstrating Biosimilarity to a 

Reference Protein Product (quality 

considerations draft guidance). 

The three draft guidances were 

published in the Federal Register on 

February 15, 2012. The scientific 

considerations draft guidance discusses 

important scientific considerations in 

demonstrating biosimilarity, including 

the totality-of-the-evidence approach 

FDA will apply to the review of 351(k) 

applications and general scientific 

principles in conducting comparative 

analyses and studies intended to 

support a demonstration of 

biosimilarity. 

The Q&A draft guidance provides 

answers to common questions from 

sponsors interested in developing 

proposed biosimilar products, biologics 

license application (BLA) holders, and 

other interested parties regarding FDA’s 

interpretation of the BPCI Act. 

The quality considerations draft 

guidance provides recommendations on 

general principles and specific factors to 

consider when conducting analytical 

studies as part of the biosimilarity 

assessment. 

IV. Purpose and Scope of the Public 

Hearing 

The purpose of this public hearing is 

twofold. First, we wish to receive 

comments on these three draft 

guidances from a broad group of 

stakeholders, such as health care 

professionals, health care institutions, 

manufacturers of biomedical products, 

interested industry and professional 

associations, patients and patient 

associations, third party payers, current 

and prospective BLA and new drug 

application (NDA) holders, and the 

public. FDA is seeking feedback, both 

general and specific, on the scientific 

considerations, Q&A, and quality 

considerations draft guidances. For 

example, FDA would like to know 

whether the scope of guidance on a 

particular topic satisfactorily addresses 

the particular question, whether there 

are issues FDA could or should have 

addressed and did not, and whether 

FDA’s thinking on each topic is 

sufficiently clear to provide meaningful 

guidance to stakeholders. In addition, 

FDA welcomes any comments that will 

help us enhance the usefulness and 

clarity of these documents. 

Second, FDA is interested in 

obtaining public input regarding the 

Agency’s priorities for development of 

future policies regarding biosimilars. 

One of the questions FDA asked at the 

November 2010 public hearing included 

what types of guidance documents for 

industry should be a priority for the 

Agency during the early period of 

implementation. In reviewing the 

comments received, we noted that many 

comments suggested the Agency begin 

with general, overarching guidances 

describing the general requirements and 

principles for biosimilar product 

development. We agree with this 

approach and have begun with the three 

draft guidance documents to be 

discussed at this public hearing. 

The Agency is interested in soliciting 

public input on the Agency’s plans for 

development of future policies 

regarding biosimilars and whether or 

not it aligns with stakeholder needs. 

The Agency is also interested in 

additional topics that should be 

considered. Topics currently under 

consideration for future guidances 

include the following: 

• 351(k) applications seeking a 

determination of interchangeability, 

• Requests for reference product 

exclusivity, 

• Naming issues, 

• Clinical pharmacology evaluation of 

biosimilar products, and 

• Q&As Regarding Implementation of 

BPCI Act (next set of questions and 

answers).1

The Agency is committed to 

continued public outreach as we move 

forward in our implementation of the 

BPCI Act. This notice is part of fulfilling 

that ongoing commitment. 

V. Attendance and Registration 

The FDA Conference Center at the 

White Oak location is a Federal facility 

with security procedures and limited 

seating. Attendance is free and will be 

on a first-come, first-served basis. 

Individuals who wish to present at the 

public hearing must register by sending 

an email to 

biosimilarspublicmtg@fda.hhs.gov on or 

before April 11, 2012, and provide 

complete contact information, including 

name, title, affiliation, address, email, 

and phone number. Those without 

email access may register by contacting 

Sandra Benton (see FOR FURTHER

INFORMATION CONTACT). You should 

identify each guidance you wish to 

comment on in your presentation, so 

that FDA can consider that in organizing 

the presentations. Individuals and 

organizations with common interests 

should consolidate or coordinate their 

presentations and request time for a 

joint presentation. FDA will do its best 

to accommodate requests to speak and 

will determine the amount of time 

allotted for each oral presentation, and 

the approximate time that each oral 

presentation is scheduled to begin. FDA 

will notify registered presenters of their 

scheduled times, and make available an 

agenda at http://www.fda.gov/Drugs/ 

NewsEvents/ucm265628.htm 

approximately 2 weeks prior to the 

public hearing. Once FDA notifies 

registered presenters of their scheduled 

times, presenters should submit an 

electronic copy of their presentation to 

biosimilarspublicmtg@fda.hhs.gov by 

May 1, 2012. 

If you need special accommodations 

because of a disability, please contact 

Sandra Benton (see FOR FURTHER

INFORMATION CONTACT) at least 7 days 

before the meeting. 

A live Web cast of this public hearing 

may be seen at http://www.fda.gov/ 

Drugs/NewsEvents/ucm265628.htm on 

the day of the public hearing. A video 

record of the public hearing will be 

available at the same Web address for 1 

year. 

VI. Notice of Hearing Under 21 CFR 

Part 15 

The Commissioner of Food and Drugs 

is announcing that the public hearing 

will be held in accordance with part 15 

(21 CFR part 15). The hearing will be 

conducted by a presiding officer, who 

will be accompanied by FDA senior 

management from the Office of the 

Commissioner, the Center for Biologics 

Evaluation and Research, and the Center 

for Drug Evaluation and Research. 

Under § 15.30(f), the hearing is 

informal and the rules of evidence do 

not apply. No participant may interrupt 

the presentation of another participant. 

Only the presiding officer and panel 

members may question any person 

during or at the conclusion of each 

presentation. Public hearings under part 

15 are subject to FDA’s policy and 

procedures for electronic media 

coverage of FDA’s public administrative 

proceedings (part 10 (21 CFR part 10, 

subpart C)). Under § 10.205, 

representatives of the electronic media 

may be permitted, subject to certain 

limitations, to videotape, film, or 

otherwise record FDA’s public 

administrative proceedings, including 

presentations by participants. The 

hearing will be transcribed as stipulated 

in § 15.30(b) (see section VIII of this 

document). To the extent that the 

conditions for the hearing, as described 

in this notice, conflict with any 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 42 / Friday, March 2, 2012 / Notices 12855 

provisions set out in part 15, this notice 

acts as a waiver of those provisions as 

specified in § 15.30(h). 

VII. Request for Comments 

Regardless of attendance at the public 

hearing, interested persons may submit 

to the Division of Dockets Management 

(see ADDRESSES) either electronic or 

written comments regarding this 

document. It is only necessary to send 

one set of comments. Identify comments 

with the docket number found in 

brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

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

Monday through Friday. 

VIII. Transcripts 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(see ADDRESSES). A transcript will also 

be available in either hard copy or on 

CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to the Division 

of Freedom of Information (ELEM– 

1029), Food and Drug Administration, 

12420 Parklawn Dr., Element Bldg., 

Rockville, MD 20857. 

Dated: February 27, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–5070 Filed 3–1–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; 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 

Child Health and Human Development 

Special Emphasis Panel, ZHD1 DSR–Z 55 1. 

Date: March 27, 2012. 

Time: 2 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6100 

Executive Boulevard, Rockville, MD 20852 

(Telephone Conference Call). 

Contact Person: Peter Zelazowski, Ph.D., 

Scientific Review Officer, Division of 

Scientific Review, Eunice Kennedy Shriver 

National Institute of Child Health and 

Human Development, NIH, 6100 Executive 

Boulevard, Room 5b01, Bethesda, MD 20892– 

7510, 301–435–6902, 

peter.zelazowski@nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: February 24, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–5017 Filed 3–1–12; 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 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 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel, PKA and PKC 

Targeting Mechanisms. 

Date: March 14, 2012. 

Time: 3 p.m. to 6 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: Carol J. Goter-Robinson, 

Ph.D., Scientific Review Officer, Review 

Branch, DEA, NIDDK, National Institutes of 

Health, Room 748, 6707 Democracy 

Boulevard Bethesda, MD 20892–5452, (301) 

594–7791, 

goterrobinsonc@extra.niddk.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: February 24, 2012. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2012–5019 Filed 3–1–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; 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 

Child Health and Human Development 

Special Emphasis Panel, HIV Disclosure SEP. 

Date: March 29–30, 2012. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue Bethesda, MD 20814. 

Contact Person: Michele C. HindiAlexander, Ph.D., Scientific Review Officer, 

Division of Scientific Review, Eunice 

Kennedy Shriver National Institute of Child 

Health and Human Development, NIH, 6100 

Executive Blvd., Room 5B01, Bethesda, MD 

20892, 301–435–8382, 

hindialm@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 


tkelley on DSK3SPTVN1PROD with NOTICES