Guidance for Food and Drug Administration Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control Information for Human Somatic Cell Therapy Investigational New Drug Applications; Availability, 19515-19516 [E8-7588-2]

Download as PDF Federal Register / Vol. 73, No. 70 / Thursday, April 10, 2008 / Notices 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 This 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 21 CFR 211.100, 211.160, and 211.165(e) have been approved under OMB Control No. 0910–0139; 21 CFR 312.23(a) and (b), 312.32(c), and Form FDA 1571 have been approved under OMB Control No. 0910–0014; and 21 CFR part 1271 has been approved under OMB Control No. 0910–0559. III. Comments Interested persons may, at any time, submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the 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 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 through FDMS only. IV. Electronic Access mstockstill on PROD1PC66 with NOTICES Persons with access to the Internet may obtain the guidance at either https:// www.fda.gov/cber/guidelines.htm or https://www.regulations.gov. Dated: April 2, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–7585 Filed 4–9–08; 8:45 am] BILLING CODE 4160–01–S VerDate Aug<31>2005 16:48 Apr 09, 2008 Jkt 214001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0206] (formerly Docket No. 2003D–0349) Guidance for Food and Drug Administration Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control Information for Human Somatic Cell Therapy Investigational New Drug Applications; 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 FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs)’’ dated April 2008. The guidance document provides to sponsors recommendations on the CMC information to include in an original IND for human somatic cell therapy. In addition, the guidance provides instructions to FDA reviewers about information to record and assess as part of the IND review. The guidance announced in this notice finalizes the draft guidance entitled ‘‘Guidance for Reviewers: Instructions and Template for Chemistry, Manufacturing, and Control Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications’’ dated August 2003. DATES: Submit written or electronic comments on agency guidances at any time. ADDRESSES: Submit written requests for single copies of the 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 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 written comments on the 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 https:// www.regulations.gov. PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 19515 FOR FURTHER INFORMATION CONTACT: Tami Belouin, 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 FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs),’’ dated April 2008. The guidance document provides to sponsors of a human somatic cell therapy IND recommendations on the CMC information to include in an original IND. In addition, the guidance provides instructions to FDA reviewers about information to record and assess as part of the IND review. This guidance will help sponsors and FDA reviewers to assess, given the phase of the investigation, whether sufficient information is provided to assure the proper identification, quality, purity, and potency of the investigational product. In the Federal Register of August 18, 2003 (68 FR 49488), FDA announced the availability of the draft guidance entitled ‘‘Draft Guidance for Reviewers: Instructions and Template for Chemistry, Manufacturing, and Control Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications’’ dated August 2003. FDA received several comments on the draft guidance and FDA considered those comments when finalizing the guidance. In addition, we revised the guidance to clarify its applicability for sponsors. The guidance announced in this notice finalizes the draft guidance dated August 2003. 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 This 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– E:\FR\FM\10APN1.SGM 10APN1 19516 Federal Register / Vol. 73, No. 70 / Thursday, April 10, 2008 / Notices 3520). The collections of information in 21 CFR 211.100, 211.160, and 211.165(e) have been approved under OMB Control No. 0910–0139; 21 CFR 312.23(a) and (b), 312.32(c), and Form FDA 1571 have been approved under OMB Control No. 0910–0014; and 21 CFR part 1271 has been approved under OMB Control No. 0910–0559. III. Comments Interested persons may, at any time, submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the 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 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 through FDMS only. IV. Electronic Access Persons with access to the Internet may obtain the guidance at either https:// www.fda.gov/cber/guidelines.htm or https://www.regulations.gov. Dated: April 2, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–7588 Filed 4–9–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0165] (formerly Docket No. 2006D–0413) Guidance for Industry on Blue Bird Medicated Feed Labels; Availability AGENCY: Food and Drug Administration, mstockstill on PROD1PC66 with NOTICES HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (#181) entitled ‘‘Blue Bird Medicated Feed Labels.’’ This guidance provides VerDate Aug<31>2005 16:48 Apr 09, 2008 Jkt 214001 new animal drug application (NADA) sponsors with the Center for Veterinary Medicine’s current thinking on what constitutes recommended content and format of representative labels for new animal drugs intended for use in the manufacture of medicated feeds. DATES: Submit written or electronic comments on agency guidances at any time. Submit written requests for single copies of the guidance to the Communications Staff (HFV–12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. Submit written comments on this 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 https:// www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Dragan Momcilovic, Center for Veterinary Medicine (HFV–220), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–453– 6856, e-mail: dragan.momcilovic@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of October 30, 2006 (71 FR 63328), FDA published a notice of availability for a draft guidance entitled ‘‘Draft Guidance for Industry: Blue Bird Medicated Feed Labels’’ giving interested persons until January 16, 2007, to comment on the draft guidance. 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 October 30, 2006. This Level 1 guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). This guidance represents the agency’s current thinking on the 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 This guidance refers to previously approved collections of information found in FDA regulations. These PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 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 21 CFR 514.1(b)(3) have been approved under OMB control number 0910–0032. III. Comments Submit written requests for single copies of the guidance to the Communications Staff (HFV–12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one selfaddressed adhesive label to assist that office in processing your requests. 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 individualproposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104–13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, call the HRSA Reports Clearance Officer on (301) 443–1129. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information shall have practical utility; (b) the accuracy of the Agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology. Proposed Project: Health Education Assistance Loan (HEAL) Program: Lender’s Application for Insurance Claim Form and Request for Collection Assistance Form (OMB No. 0915– 0036)—Extension The HEAL program provided federally insured loans to students in certain health professions to pay for their educational costs. HEAL Lenders use the Lender’s Application for Insurance Claim to request payment from the Federal Government for E:\FR\FM\10APN1.SGM 10APN1

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[Federal Register Volume 73, Number 70 (Thursday, April 10, 2008)]
[Notices]
[Pages 19515-19516]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-7588]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0206] (formerly Docket No. 2003D-0349)


Guidance for Food and Drug Administration Reviewers and Sponsors: 
Content and Review of Chemistry, Manufacturing, and Control Information 
for Human Somatic Cell Therapy Investigational New Drug Applications; 
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 FDA Reviewers and 
Sponsors: Content and Review of Chemistry, Manufacturing, and Control 
(CMC) Information for Human Somatic Cell Therapy Investigational New 
Drug Applications (INDs)'' dated April 2008. The guidance document 
provides to sponsors recommendations on the CMC information to include 
in an original IND for human somatic cell therapy. In addition, the 
guidance provides instructions to FDA reviewers about information to 
record and assess as part of the IND review. The guidance announced in 
this notice finalizes the draft guidance entitled ``Guidance for 
Reviewers: Instructions and Template for Chemistry, Manufacturing, and 
Control Reviewers of Human Somatic Cell Therapy Investigational New 
Drug Applications'' dated August 2003.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the 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 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 written comments on the 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 https://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Tami Belouin, 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 FDA Reviewers and Sponsors: Content and Review of 
Chemistry, Manufacturing, and Control (CMC) Information for Human 
Somatic Cell Therapy Investigational New Drug Applications (INDs),'' 
dated April 2008. The guidance document provides to sponsors of a human 
somatic cell therapy IND recommendations on the CMC information to 
include in an original IND. In addition, the guidance provides 
instructions to FDA reviewers about information to record and assess as 
part of the IND review. This guidance will help sponsors and FDA 
reviewers to assess, given the phase of the investigation, whether 
sufficient information is provided to assure the proper identification, 
quality, purity, and potency of the investigational product.
    In the Federal Register of August 18, 2003 (68 FR 49488), FDA 
announced the availability of the draft guidance entitled ``Draft 
Guidance for Reviewers: Instructions and Template for Chemistry, 
Manufacturing, and Control Reviewers of Human Somatic Cell Therapy 
Investigational New Drug Applications'' dated August 2003. FDA received 
several comments on the draft guidance and FDA considered those 
comments when finalizing the guidance. In addition, we revised the 
guidance to clarify its applicability for sponsors. The guidance 
announced in this notice finalizes the draft guidance dated August 
2003.
    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

    This 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-

[[Page 19516]]

3520). The collections of information in 21 CFR 211.100, 211.160, and 
211.165(e) have been approved under OMB Control No. 0910-0139; 21 CFR 
312.23(a) and (b), 312.32(c), and Form FDA 1571 have been approved 
under OMB Control No. 0910-0014; and 21 CFR part 1271 has been approved 
under OMB Control No. 0910-0559.

III. Comments

    Interested persons may, at any time, submit to the Division of 
Dockets Management (see ADDRESSES) written or electronic comments 
regarding the 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 
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 
through FDMS only.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either https://www.fda.gov/cber/guidelines.htm or https://
www.regulations.gov.

    Dated: April 2, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-7588 Filed 4-9-08; 8:45 am]
BILLING CODE 4160-01-S

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