Federal Register / Vol. 76, No. 155 / Thursday, August 11, 2011 / Notices 49773 

other vaccines due to practical 

considerations related to manufacturing 

and cost. Moreover, the schedule of 

vaccines subject to NCVIA is not static 

and is updated regularly. The Agency 

therefore will consider a vaccine 

manufacturer’s request for an exemption 

to the linear bar code requirement for 

any of its other licensed vaccines in 

addition to childhood vaccines. 

Note that, as FDA stated in the 

preamble to the final rule, the Agency 

continues to emphasize that the general 

exemption provision in § 201.25(d)(1)(ii) 

is intended to be used in rare cases (69 

FR 9120 at 9131). FDA believes that its 

revised response to Q12 is consistent 

with that view because it is narrowly 

tailored. Further, as alternative 

technologies continue to advance, the 

Agency intends to assess these 

technologies in relation to current bar 

coding practices and other FDA 

initiatives, such as efforts to further 

enhance the security of the drug supply 

chain through use of a standardized 

numerical identifier for uniquely 

identifying prescription drug packages, 

and the establishment of a unique 

device identification system for medical 

devices. 

In the Federal Register of September 

7, 2010 (75 FR 54347), FDA announced 

the availability of a draft guidance 

entitled ‘‘Guidance for Industry: Bar 

Code Label Requirements—Questions 

and Answers (Question 12 Update)’’ 

dated August 2010. FDA received 

several comments on the draft guidance 

and those comments were considered as 

the guidance was finalized. The 

guidance announced in this notice 

finalizes the draft guidance dated 

August 2010 and incorporates a revised 

response to question 12 into the 

guidance entitled ‘‘Guidance for 

Industry: Bar Code Label 

Requirements—Questions and 

Answers’’. In addition, editorial changes 

were made to the guidance to improve 

clarity. 

The guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents FDA’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. Paperwork Reduction Act of 1995 

The guidance refers to previously 

approved collections of information 

found in FDA regulations. The 

collection of information in part 201 has 

been approved under OMB control 

number 0910–0537. 

III. 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. It is no longer necessary to 

send two copies of mailed 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either http:// 

www.fda.gov/BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/Guidances/default.htm or 

http://www.regulations.gov. 

Dated: August 4, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–20385 Filed 8–10–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0324] 

International Conference on 

Harmonisation; Guidance on E16 

Biomarkers Related to Drug or 

Biotechnology Product Development: 

Context, Structure, and Format of 

Qualification Submissions; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled ‘‘E16 

Biomarkers Related to Drug or 

Biotechnology Product Development: 

Context, Structure, and Format of 

Qualification Submissions.’’ The 

guidance was prepared under the 

auspices of the International Conference 

on Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use (ICH). 

The guidance describes 

recommendations regarding the context, 

structure, and format of qualification 

submissions for clinical and nonclinical 

genomic biomarkers related to 

development of drug or biotechnology 

products, including translational 

medicine approaches, 

pharmacokinetics, pharmacodynamics, 

and efficacy and safety aspects. The 

guidance is intended to create a 

harmonized recommended structure for 

biomarker qualification applications 

that will foster consistency of 

applications across regions and facilitate 

discussions with and among regulatory 

authorities. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Division of Drug Information (HFD– 

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, rm. 2201, Silver Spring, 

MD 20993–0002, or the Office of 

Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, Rockville, MD 

20852–1448. Send one self-addressed 

adhesive label to assist the office in 

processing your requests. The guidance 

may also be obtained by mail by calling 

CBER at 1–800–835–4709 or 301–827– 

1800. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

Submit electronic comments on the 

guidance 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. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: 

Federico Goodsaid, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2148, 

Silver Spring, MD 20903–0002, 301– 

796–1535; or 

Jennifer Catalano, Center for Biologics 

and Evaluation Research (HFM–735), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448, 301–827–0706. 

Regarding the ICH: 

Michelle Limoli, Office of International 

Programs (HFG–1), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–4480. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 


srobinson on DSK4SPTVN1PROD with NOTICES
49774 Federal Register / Vol. 76, No. 155 / Thursday, August 11, 2011 / Notices 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory agencies. 

ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products among three 

regions: The European Union, Japan, 

and the United States. The six ICH 

sponsors are the European Commission; 

the European Federation of 

Pharmaceutical Industries Associations; 

the Japanese Ministry of Health, Labour, 

and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and the IFPMA, as well as 

observers from the World Health 

Organization, Health Canada, and the 

European Free Trade Area. 

In the Federal Register of July 30, 

2009 (74 FR 38033), FDA published a 

notice announcing the availability of a 

draft guidance entitled ‘‘E16 Genomic 

Biomarkers Related to Drug Response: 

Context, Structure, and Format of 

Qualification Submissions.’’ The notice 

gave interested persons an opportunity 

to submit comments by September 28, 

2009. 

After consideration of the comments 

received and revisions to the guidance, 

a final draft of the guidance was 

submitted to the ICH Steering 

Committee and endorsed by the three 

participating regulatory agencies in 

September 2010. 

The guidance provides 

recommendations on the context, 

structure, and format of qualification 

submissions as follows: 

• The proposed context of use of a 

biomarker corresponds to the data 

supporting its qualification. The context 

of use of a biomarker in a biomarker 

qualification can be narrow or broad— 

the biomarker(s) might be useful for 

only a single drug or biotechnology 

product, for several drug or 

biotechnology products in a drug class, 

or even across several drug classes. 

• The structure of the submission 

should be consistent regardless of the 

context proposed and flexible enough to 

deal with the specific attributes of each 

submission. In addition, use of the 

recommended structure should facilitate 

submission and review of future 

biomarker qualification submissions 

expanding the use of the biomarker to 

new contexts, as would be the case if, 

for example, a nonclinical context of use 

expands to a clinical context of use. 

• The format of the data for qualifying 

a biomarker can vary significantly 

depending on the context. The format 

should support an evaluation of the data 

and can include reports, tabulations, 

and raw data (if requested by regulatory 

authorities according to the relevant 

practices in place). 

The application structure described in 

this guidance is intended for biomarker 

qualification submissions after 

sufficient supporting data have been 

generated. However, this structure can 

also be considered for submissions 

intended to obtain scientific advice from 

regulatory authorities before or during 

the generation of the biomarker data 

intended to support qualification. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents 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. It is no longer necessary to 

send two copies of mailed 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. Electronic Access 

Persons with access to the Internet 

may obtain the document at http://www.

regulations.gov, http://www.fda.gov/

Drugs/GuidanceComplianceRegulatory

Information/Guidances/default.htm, or 

http://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm. 

Dated: August 4, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–20386 Filed 8–10–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Cellular, Tissue and Gene Therapies 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Cellular, Tissue 

and Gene Therapies Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on September 22 and 23, 2011, 

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

Location: Hilton Hotel, Washington, 

DC North/Gaithersburg, 620 Perry 

Pkwy., Gaithersburg, MD 20977, 301– 

977–8900. For those unable to attend in 

person, the meeting will also be 

available by Web cast. On September 22, 

2011, the link for the Web cast is 

available at http://fda.yorkcast.com/

webcast/Viewer/?peid=637f14248dca

4236a5f9a3b622e6501e1d. On 

September 23, 2011, the link for the 

Web cast is available at http://fda.

yorkcast.com/webcast/Viewer/?peid

=2e8b3eb7638d42ca9652c328a854efb

51d. 

Contact Person: Gail Dapolito or 

Sheryl Clark (HFM–71), Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20853, 

301–827–0314, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. Please call the Information Line for 

up-to-date information on this meeting. 

A notice in the Federal Register about 

last minute modifications that impact a 


srobinson on DSK4SPTVN1PROD with NOTICES