49772 Federal Register / Vol. 76, No. 155 / Thursday, August 11, 2011 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0426] 

Guidance for Industry: Bar Code Label 

Requirements—Questions and 

Answers; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a document entitled 

‘‘Guidance for Industry: Bar Code Label 

Requirements—Questions and 

Answers’’ dated August 2011. The 

guidance announced in this notice 

amends the October 2006 guidance 

document of the same title by 

incorporating a revised response to 

question 12 (Q12). The revised response 

concerns the ability of vaccine 

manufacturers to use alternative coding 

technologies to the linear bar code 

requirement. The guidance announced 

in this notice finalizes the draft 

guidance entitled ‘‘Guidance for 

Industry: Bar Code Label 

Requirements—Questions and Answers 

(Question 12 Update)’’ dated August 

2010, and is superseding the guidance 

entitled ‘‘Guidance for Industry: Bar 

Code Label Requirements—Questions 

and Answers’’ dated October 2006. 

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 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

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: 

Benjamin A. Chacko, 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 document entitled ‘‘Guidance for 

Industry: Bar Code Label 

Requirements—Questions and 

Answers’’ dated August 2011. In the 

Federal Register of February 26, 2004 

(69 FR 9120), FDA published a final rule 

(the February 2004 final rule) requiring 

certain human drug and biological 

products to have on their labels a linear 

bar code that contains, at a minimum, 

the drug’s national drug code number 

(§ 201.25 (21 CFR 201.25)). To explain 

how the bar code label requirements 

apply to specific products or 

circumstances, in the Federal Register 

of April 27, 2006 (71 FR 24856), FDA 

announced the availability of a guidance 

entitled ‘‘Guidance for Industry: Bar 

Code Label Requirement—Questions 

and Answers’’ that was revised several 

months later, as discussed in the 

Federal Register of October 5, 2006 (71 

FR 58739). Since then, FDA has 

received additional information 

concerning vaccines and the linear bar 

code requirement. In light of this 

information, we are incorporating a new 

response to question 12 in the guidance 

document entitled ’’Guidance for 

Industry: Bar Code Label 

Requirements—Questions and 

Answers’’. We are providing a revised 

response to manufacturers of licensed 

vaccines in connection with the use of 

alternative coding technologies because 

it has become increasingly clear that 

vaccines present unique concerns in the 

bar coding context, particularly with 

respect to compliance with 

recordkeeping and mandatory adverse 

event reporting requirements that are 

specific to the administration of 

childhood vaccines. These concerns are 

particularly important because vaccines 

are typically administered in an office 

or clinic which may have limited 

administrative support. For example, 

health care providers who administer a 

vaccine that is subject to the 

requirements in the National Childhood 

Vaccine Injury Act of 1986 (Pub. L. 99– 

660) (42 U.S.C. 300aa–25(a))) (NCVIA) 

are required to ensure that there is 

recorded in the vaccine recipient’s 

permanent medical record (or in a 

permanent office log or file) the date the 

vaccine was administered, the 

manufacturer, lot number of the 

vaccine, and the name, address, and 

title of the person administering the 

vaccine (42 U.S.C. 300aa–25(a)). Manual 

data entry of this information requires 

rigorous procedures to ensure accurate 

records as not all of this information is 

encoded and clerical recording errors 

can diminish the value of information 

available for mandatory adverse event 

reporting. Furthermore, inaccurate 

recording of a lot number may delay or 

misdirect FDA’s investigation of an 

adverse event. At this time, FDA 

believes that two dimensional 

symbology technology has advanced 

such that health care providers may 

wish to invest in the technology to 

capture information from a two 

dimensional code because, through use 

of this technology, they may more 

effectively be able to address the 

reporting requirements reflected in 

NCVIA. 

FDA also believes that enhanced 

compliance with NCVIA will in turn 

enable compliance with the mandatory 

reporting of adverse events by health 

care providers under the Vaccine 

Adverse Event Reporting System 

(VAERS), administered jointly by the 

Centers for Disease Control and 

Prevention and FDA. For example, 

complete automatic entry of vaccine 

information would facilitate accurate 

reporting to VAERS, decrease incorrect 

VAERS entries, and would facilitate 

rapid, accurate entry into immunization 

registries. Finally, the ready availability 

of information in machine readable 

format will enable more efficient 

electronic recordation of information, 

including lot number and vaccine 

expiration dates. 

For these reasons, FDA now will 

consider requests from vaccine 

manufacturers who request to use 

alternate coding technologies, such as 

two dimensional symbology, that 

encode lot number and expiration date 

information, for an exemption under 

§ 201.25(d)(1)(ii) to the linear bar code 

requirement. In particular, the Agency 

will consider granting such an 

exemption request under 

§ 201.25(d)(1)(ii) on the grounds that an 

alternative regulatory program, 

comprised of alternative technology 

such as two dimensional symbology 

used to facilitate compliance with 

requirements of public health programs 

applicable to childhood vaccines, could 

render the use of linear bar codes 

unnecessary for patient safety, and we 

would consider granting a request for an 

exemption to the bar code requirement 

under § 201.25(d)(1)(ii) in connection 

with such use. FDA recognizes that it 

may be infeasible for a vaccine 

manufacturer to implement alternate 

coding technology only for childhood 

vaccines that are subject to NCVIA, 

while retaining linear bar coding for its 


srobinson on DSK4SPTVN1PROD with NOTICES
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