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draft guidance. 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the draft guidance is appropriate for 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 FDA’s draft guidance 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

3056 Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Notices 

III. Commentsuidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. Interested persons may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding the draft 

guidance. 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 the 

brackets in the heading of this 

document. A copy of the draft guidance 

and received comments are available 

for public examination 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

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

or http://www.regulations.gov. 

Dated: January 13, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–919 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–0510] 

Draft Guidance for Industry: 

Submission of Laboratory Packages 

by Accredited Laboratories; 

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: Submission of 

Laboratory Packages by Accredited 

Laboratories.’’ The draft guidance 

document provides information and 

recommendations about accreditation 

standards for laboratories and the 

quality and type of data that accredited 

laboratories produce to support testing 

results submitted to FDA about the 

admissibility of detained articles offered 

for import. We are taking this action 

under a recommendation made by the 

President’s Interagency Working Group 

on Import Safety (Working Group). 

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 Executive Operations (HFC–2), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857. 

Send one self-addressed adhesive label 

to assist that office in processing your 

requests. 

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: 

Donna Porter, Division of Field Science 

(HFA–141), Office of Regulatory Affairs, 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–7605. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document entitled ‘‘Guidance for 

Industry: Submission of Laboratory 

Packages by Accredited Laboratories.’’ 

The draft guidance is about 

accreditation standards for laboratories 

and about the quality and type of data 

that accredited laboratories should 

produce in support of testing results 

submitted to FDA pertaining to the 

admissibility of detained articles offered 

for import of all product types (i.e., 

biological products, drugs, devices, and 

food) that we regulate. FDA is taking 

this action under a recommendation 

made by the President’s Interagency 

Working Group on Import Safety 

(Working Group). The Working Group 

was to conduct a comprehensive review 

of the U.S. import system and identify 

ways to further increase the safety of 

imports entering the country, and it 

presented its initial findings to the 

President on September 10, 2007, in a 

report entitled ‘‘Protecting American 

Consumers Every Step of the Way: A 

Strategic Framework for Continual 

Improvement in Import Safety.’’ 

On November 6, 2007, the Working 

Group presented to the President its 

Import Safety Action Plan (Action Plan), 

which contains short- and long-term 

recommendations for continuing to 

improve the safety of imports entering 

the United States. The Action Plan 

recommended that FDA issue guidance 

that ‘‘would set standards for the 

sampling and testing of imported 

products, including the use of 

accredited laboratories submitting data 

to FDA to assist in evaluating whether 

an appearance of a violation may be 

resolved.’’ 

The issuance of the draft guidance is, 

therefore, consistent with the Action 

Plan and also 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 

requirements of the applicable statutes 

and regulations. 

II. Comments 

The draft guidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. Interested persons may 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding the draft 

guidance. 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. A copy of the draft guidance 

and received comments are available for 

public examination 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 draft guidance at either 

http://www.fda.gov/ora or http:// 

www.regulations.gov. 

mstockstill on PROD1PC66 with NOTICES