3054 Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Notices 

studies. In coordination with the Office 

of Planning, Research and Evaluation, 

DPPE coordinates ANA’s performance 

goals. 

Dated: January 9, 2009. 

Daniel C. Schneider, 

Acting Assistant Secretary for Children and 

Families. 

[FR Doc. E9–983 Filed 1–15–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0001] 

Draft Guidance for Industry on 

Standards for Securing the Drug 

Supply Chain—Standardized 

Numerical Identification for 

Prescription Drug Packages; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Standards for 

Securing the Drug Supply Chain— 

Standardized Numerical Identification 

for Prescription Drug Packages.’’ This 

draft guidance is being issued under the 

Federal Food, Drug, and Cosmetic Act 

(the act), which requires FDA to develop 

standardized numerical identifiers for 

prescription drugs. We are also 

requesting responses from interested 

stakeholders to questions posed in this 

Federal Register notice related to the 

draft guidance. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by April 16, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002 or 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 

that office in processing your requests. 

The draft guidance may also be obtained 

by mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. Submit written 

comments on the draft guidance to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Submit electronic comments 

to http://www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Ilisa B.G. Bernstein, Office of the 

Commissioner/Office of Policy, 

Food and Drug Administration, 

10903 New Hampshire Ave., Silver 

Spring, MD 20993–0002, 301–796– 

4840, e-mail: 

ilisa.bernstein@fda.hhs.gov; 

Stephen Ripley, Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852, 301–827– 

6210, e-mail: 

Stephen.ripley@fda.hhs.gov; 

Jennifer Devine, Center for Drug 

Evaluation and Research, 10903 

New Hampshire Ave.,Silver Spring, 

MD 20993–0002, 301–796–3347, email: Jennifer.devine@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Draft Guidance for Industry on 

Standards for Securing the Drug Supply 

Chain—Standardized Numerical 

Identification for Prescription Drug 

Packages.’’ On September 27, 2007, the 

Food and Drug Administration 

Amendments Act of 2007 (FDAAA) 

(Public Law 110–85) was signed into 

law. Section 913 of this legislation 

created section 505D of the act, which 

requires the Secretary of Health and 

Human Services (the Secretary) to 

develop standards and identify and 

validate effective technologies for the 

purpose of securing the drug supply 

chain against counterfeit, diverted, 

subpotent, substandard, adulterated, 

misbranded, or expired drugs. Section 

505D of the act directs the Secretary to 

consult with specific entities to 

prioritize and develop standards for 

identification, validation, 

authentication, and tracking and tracing 

of prescription drugs. No later than 30 

months after the date of enactment of 

FDAAA, the statute also directs the 

Secretary to develop a standardized 

numerical identifier (SNI) to be applied 

to a prescription drug at the point of 

manufacturing and repackaging at the 

package or pallet level, sufficient to 

facilitate the identification, validation, 

authentication, and tracking and tracing 

of the prescription drug. An SNI applied 

at the point of repackaging is to be 

linked to the SNI applied at the point of 

manufacturing, and to the extent 

practicable, the SNI should be 

harmonized with international 

consensus standards for such an 

identifier. (See section 505D(b)(2) of the 

act.) The provisions in section 505D(b) 

of the act complement and build on 

FDA’s longstanding efforts to further 

secure the U.S. drug supply. 

FDA sought public comment on 

specific questions related to 

development of an SNI. We received 59 

comments from a range of stakeholders 

including manufacturers, wholesalers, 

pharmacies, trade and health 

professional organizations, technology 

vendors, health professionals, 

consumers, and state governments. The 

standards included in this draft 

guidance are based on information 

received in response to our request for 

comment and the agency’s familiarity 

with identification standards already in 

use for certain prescription biologics. 

This draft guidance addresses only 

package-level SNI. Linking of a 

repackager SNI to a manufacturer SNI is 

not addressed in this guidance. 

Additionally, standards for track and 

trace, authentication, and validation are 

not included in this guidance. This draft 

guidance is intended to be the first of 

several guidances and regulations that 

FDA may issue to implement section 

505D of the act; issuance of this 

guidance is intended to assist with the 

development of standards and systems 

for identification, authentication, and 

tracking and tracing of prescription 

drugs. 

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 Standards for Drug Supply Chain 

Security—Standardized Numerical 

Identification for Prescription Drug 

Packages. 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. Request for Information 

To assist us in finalizing the draft 

guidance and aid us in future guidance 

development and rulemaking related to 

section 505D of the act, we are seeking 

responses from interested stakeholders 

on the following questions. We also 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Notices 3055 

welcome comment on any aspect of the 

draft guidance. 

1. We believe that the serialized 

National Drug Code (sNDC) described in 

the draft guidance is appropriate for 

package level identification for most 

prescription drugs; however, it might 

not be useful at the pallet or other 

intermediate level, such as the case. We 

did not receive many comments related 

to standards for numerical identification 

at the case or pallet level and would like 

broader input on this subject. Please 

comment on whether there are any 

standards that would be appropriate for 

serialization or other numerical 

identification at the case or pallet level. 

2. Some comments recommended that 

the SNI allow for alpha-numeric serial 

numbers in order to increase the choices 

for the numbers. FDA’s draft guidance 

recommends that the SNI for most 

prescription drug packages be an sNDC, 

consisting of the NDC plus a unique 8- 

digit numerical serial number. Given the 

FDA recommendation for SNI, please 

comment on the necessity of having the 

serial number allow for alpha-numeric 

possibilities and under what standards 

this might be achieved. 

3. Blood and blood components 

currently use either the ISBT 128 

standard or Codabar for product package 

identification. In addition, 

hematopoietic stem cells derived from 

peripheral and cord blood use the ISBT 

128 standard for product package 

identification. Please comment on 

whether these standards should be 

designated as the SNI for such products. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified 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. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the document at http:// 

www.fda.gov/cder/guidance/index.htm, 

http://www.fda.gov/cber/ 

guidelines.htm, or http:// 

www.regulations.gov. 

Dated: January 8, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–833 Filed 1–15–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0659] 

Draft Guidance for Industry: Current 

Good Tissue Practice (CGTP) and 

Additional Requirements for 

Manufacturers of Human Cells, 

Tissues, and Cellular and TissueBased Products (HCT/Ps); Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft document entitled 

‘‘Guidance for Industry: Current Good 

Tissue Practice (CGTP) and Additional 

Requirements for Manufacturers of 

Human Cells, Tissues, and Cellular and 

Tissue-Based Products (HCT/Ps)’’ dated 

January 2009. The draft guidance 

document provides establishments that 

manufacture HCT/Ps with 

recommendations for complying with 

CGTP requirements. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by April 16, 2009. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Office of Communication, Training, and 

Manufacturers Assistance (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 draft 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 draft 

guidance document. 

Submit written comments on the draft 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Brenda R. Friend, 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 document entitled ‘‘Guidance for 

Industry: Current Good Tissue Practice 

(CGTP) and Additional Requirements 

for Manufacturers of Human Cells, 

Tissues, and Cellular and Tissue-Based 

Products (HCT/Ps)’’ dated January 2009. 

This guidance provides establishments 

that manufacture HCT/Ps with 

recommendations for complying with 

CGTP requirements under part 1271 (21 

CFR Part 1271), subpart D (Current 

Good Tissue Practice), and requirements 

under part 1271, subpart E (Additional 

Requirements for Establishments 

Described in § 1271.10). This guidance 

also addresses whether the 

establishment registration and HCT/P 

listing requirements under part 1271, 

subparts A and B apply in certain 

instances. 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent 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 requirement 

of the applicable statutes and 

regulations. 

II. 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). The collections 

of information in part 1271, subparts D 

and E, and §§ 1271.10 and 1271.21 have 

been approved under OMB Control No. 

0910–0543. 

mstockstill on PROD1PC66 with NOTICES