8886 Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Notices 

FOR FURTHER INFORMATION CONTACT: 

Sandra Benton, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

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

Silver Spring, MD 20993–0002, 301– 

796–1042; or Stephen Ripley, Center for 

Biologics Evaluation and Research 

(HFM–17), Food and Drug 

Administration, 1401 Rockville Pike, 

Suite 200N, Rockville, MD 20852–1448, 

301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Biosimilars: Questions and Answers 

Regarding Implementation of the 

Biologics Price Competition and 

Innovation Act of 2009.’’ This draft 

guidance provides answers to common 

questions from sponsors interested in 

developing proposed biosimilar 

products, BLA holders, and other 

interested parties regarding FDA’s 

interpretation of the BPCI Act. 

The BPCI Act, enacted as part of the 

Patient Protection and Affordable Care 

Act (Pub. L. 111–148) on March 23, 

2010, created an abbreviated licensure 

pathway under section 351(k) of the 

Public Health Service Act (42 U.S.C. 

262(k)) for biological products 

demonstrated to be biosimilar to, or 

interchangeable with, an FDA-licensed 

biological reference product. This draft 

guidance describes FDA’s current 

interpretation of certain statutory 

requirements added by the BPCI Act 

and includes questions and answers 

(Q&As) in the following categories: 

• Biosimilarity or Interchangeability 

• Provisions Related to Requirement to 

Submit a BLA for a ‘‘Biological 

Product’’ 

• Exclusivity 

The Q&A format is intended to promote 

transparency and facilitate development 

programs for proposed biosimilar 

products by addressing questions that 

may arise in the early stages of 

development. In addition, these Q&As 

respond to questions the Agency has 

received from prospective BLA and new 

drug application (NDA) applicants 

regarding the appropriate statutory 

authority under which certain products 

will be regulated. 

FDA intends to update this guidance 

to include additional Q&As as 

appropriate and intends to post 

information by Q&A number on FDA’s 

Web site regarding the publication date 

of draft guidance Q&As for comment, 

the comment period, and the 

publication date of final guidance 

Q&As. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on this topic. It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

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. 

III. The Paperwork Reduction Act 

This draft guidance describes 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act (the PRA) 

(44 U.S.C. 3501–3520). In particular, the 

draft guidance refers to information 

collections related to the submission of 

a 351(k) application. In accordance with 

the PRA, FDA is soliciting public 

comment, in a separate document 

published elsewhere in this issue of the 

Federal Register (see ‘‘Agency 

Information Collection Activities; 

Proposed Collection; Comment Request; 

General Licensing Provisions; Section 

351(k) Biosimilar Applications’’) on the 

information collection associated with 

the submission of a 351(k) application. 

FDA will also seek OMB approval for 

this information collection. 

In addition, this draft guidance 

references other information collections 

that are already approved by OMB and 

are not expected to change as a result of 

the draft guidance. This includes 

information collections related to the 

submission of (1) an investigational 

NDA, which is covered under 21 CFR 

part 312 and approved under OMB 

control number 0910–0014; (2) an NDA, 

which is covered under 21 CFR 314.50 

and approved under OMB control 

number 0910–0001; (3) a biologics 

license application, which is covered 

under 21 CFR part 601 and approved 

under OMB control number 0910–0338; 

and (4) labeling, which is covered under 

21 CFR 201.57 and approved under 

OMB control number 0910–0572. 

The draft guidance also discusses the 

retention of reserve samples of the 

biological products used in comparative 

clinical pharmacokinetic and/or 

pharmacodynamic studies intended to 

support a proposed 351(k) application. 

Such reserve samples are samples of 

products or other physical objects 

exempt under 5 CFR 1320.3(h)(2), and 

thus not considered ‘‘information’’ as 

that term is defined under the PRA. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

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

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, http://www.fda.gov/

BiologicsBloodVaccines/

GuidanceCompliance

RegulatoryInformation/default.htm, or 

http://www.regulations.gov. 

Dated: February 9, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–3549 Filed 2–14–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0001] 

Food and Drug Administration Clinical 

Trial Requirements, Regulations, 

Compliance, and Good Clinical 

Practice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop. 

SUMMARY: The Food and Drug 

Administration (FDA) Detroit District 

Office, in co-sponsorship with the 

Society of Clinical Research Associates 

(SoCRA) is announcing a public 

workshop. The public workshop on 

FDA’s clinical trial requirements is 

designed to aid the clinical research 

professional’s understanding of the 

mission, responsibilities, and authority 

of FDA and to facilitate interaction with 

FDA representatives. The program will 

focus on the relationships among FDA 

and clinical trial staff, investigators, and 

institutional review boards (IRB). 

Individual FDA representatives will 

discuss the informed consent process 

and informed consent documents; 

regulations relating to drugs, devices, 

and biologics; as well as inspections of 

clinical investigators, IRB, and research 

sponsors. 

Date and Time: The public workshop 

will be held on May 9 and 10, 2012, 

from 8 a.m. to 5 p.m. 


sroberts on DSK5SPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 31 / Wednesday, February 15, 2012 / Notices 8887 

Location: The public workshop will 

be held at the Marriott Ann Arbor 

Ypsilanti at Eagle Crest, 1275 S. Huron 

St., Ypsilanti, MI 48197, 800–606–7044. 

Contact: Society of Clinical Research 

Associates (SoCRA), 530 West Butler 

Ave., Suite 109, Chalfont, PA 18914, 

1–800–762–7292 or 215–822–8644, 

FAX: 215–822–8633, email: 

SoCRAmail@aol.com, Web site: http:// 

www.SoCRA.org. (FDA has verified the 

Web site addresses throughout this 

document, but we are not responsible 

for any subsequent changes to the Web 

sites after this document publishes in 

the Federal Register.); or Nancy 

Bellamy, Food and Drug 

Administration, Detroit District Office, 

300 River Pl., Suite 5900, Detroit, MI 

48207, 313–393–8143, Fax: 313–393– 

8139, email: 

nancy.bellamy@fda.hhs.gov. 

Accommodations: Attendees are 

responsible for their own 

accommodations. Please mention 

SoCRA to receive the hotel room rate of 

$119 plus applicable taxes (available 

until April 17, 2012 or until the SoCRA 

room block is filled). 

COST OF REGISTRATION

SoCRA member ....................... $575 

SoCRA nonmember (includes 

membership) ......................... 650 

Federal Government member .. 450 

Federal Government nonmember ................................. 525 

FDA Employee ......................... * 

* (Free) Fee Waived. 

If you need special accommodations 

due to a disability, please contact 

SoCRA (see Contact) at least 21 days in 

advance. Extended periods of question 

and answer and discussion have been 

included in the program schedule. 

SoCRA designates this educational 

activity for a maximum of 13.3 

Continuing Education Credits for 

SoCRA CE and Nurse CNE. SoCRA 

designates this live activity for a 

maximum of 13.3 AMA PRA Category 1 

Credit(s) TM. Physicians should claim 

only the credit commensurate with the 

extent of their participation. CME for 

Physicians: SoCRA is accredited by the 

Accreditation Council for Continuing 

Medical Education to provide 

continuing medical education for 

physicians. CNE for Nurses: SoCRA is 

an approved provider of continuing 

nursing education by the Pennsylvania 

State Nurses Association (PSNA), an 

accredited approver by the American 

Nurses Credentialing Center’s 

Commission on Accreditation (ANCC). 

ANCC/PSNA Provider Reference 

Number: 205–3–A–09. 

Registration Instructions: To register, 

please submit a registration form with 

your name, affiliation, mailing address, 

telephone, fax number, and email, along 

with a check or money order payable to 

‘‘SoCRA’’. Mail to: SoCRA (see Contact 

for address). To register via the Internet, 

go to http://www.socra.org/html/ 

FDA_Conference.htm. Payment by 

major credit card is accepted (Visa/ 

MasterCard/AMEX only). For more 

information on the meeting registration, 

or for questions on the workshop, 

contact SoCRA (see Contact). 

SUPPLEMENTARY INFORMATION: The 

public workshop helps fulfill the 

Department of Health and Human 

Services’ and FDA’s important mission 

to protect the public health. The 

workshop will provide those engaged in 

FDA-regulated (human) clinical trials 

with information on a number of topics 

concerning FDA requirements related to 

informed consent, clinical investigation 

requirements, IRB inspections, 

electronic record requirements, and 

investigator initiated research. Topics 

for discussion include the following: (1) 

What FDA Expects in a Pharmaceutical 

Clinical Trial; (2) Adverse Event 

Reporting—Science, Regulation, Error, 

and Safety; (3) Part 11 Compliance— 

Electronic Signatures; (4) Informed 

Consent Regulations; (5) IRB 

Regulations and FDA Inspections; (6) 

Keeping Informed and Working 

Together; (7) FDA Conduct of Clinical 

Investigator Inspections; (8) Meetings 

With FDA: Why, When, and How; (9) 

Investigator Initiated Research; (10) 

Medical Device Aspects of Clinical 

Research; (11) Working With FDA’s 

Center for Biologics Evaluation and 

Research; (12) The Inspection is Over— 

What Happens Next? Possible FDA 

Compliance Actions; (13) Ethical Issues 

in Subject Enrollment; (14) Medical 

Device Aspects of Clinical Research; 

(15) Are We There Yet? An Overview of 

the FDA GCP Program. 

FDA has made education of the drug 

and device manufacturing community a 

high priority to help ensure the quality 

of FDA-regulated drugs and devices. 

The public workshop helps to achieve 

objectives set forth in section 406 of the 

FDA Modernization Act of 1997 (21 

U.S.C. 393) which includes working 

closely with stakeholders and 

maximizing the availability and clarity 

of information to stakeholders and the 

public. The public workshop also is 

consistent with the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (Pub. L. 104–121) as outreach 

activities by Government Agencies to 

small businesses. 

Dated: February 9, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–3553 Filed 2–14–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director Notice of 

Establishment 

Pursuant to the Federal Advisory 

Committee Act, as amended (5 U.S.C. 

App), the Director, National Institutes of 

Health (NIH), announces the 

establishment of the National Center for 

Advancing Translational Sciences 

Advisory Council (Council) and the 

Cures Acceleration Network Review 

Board (Board), in the National Center for 

Advancing Translation Sciences 

(NCATS). 

The Council will advise, assist, 

consult with, and make 

recommendations to the Secretary of 

Health and Human Services (Secretary), 

the Director, National Institutes of 

Health (NIH) and the Director, National 

Center for Advancing Translational 

Sciences (NCATS, also referred to as 

Center) on matters related to the 

activities carried out by and through the 

Center and the policies respecting these 

activities. 

The Board will advise, and provide 

recommendation to, the Director, 

NCATS, with respect to (1) policies, 

programs, and procedures for carrying 

out the duties of the Director, NCATS, 

under section 480 of the PHS Act; and 

(2) significant barriers to successful 

translation of basic science into clinical 

application (including issues under the 

purview of other agencies and 

departments). 

Duration of each committee is two 

years from the date the Charter is filed. 

Dated: February 7, 2012. 

Francis S. Collins, 

Director, National Institutes of Health. 

[FR Doc. 2012–3572 Filed 2–14–12; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Deafness and 

Other Communication Disorders 

Notice of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 


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