Draft Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products; Availability, 59635-59636 [E8-24052]

Download as PDF sroberts on PROD1PC70 with NOTICES Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Notices Science Board BPA Subcommittee. The Science Board will discuss 2009 agenda topics. The Science Board will also hear an overview of current methods for detection of contaminants in FDAregulated products. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ohrms/ dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the appropriate advisory committee link. 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The contact person will notify interested persons regarding their request to speak by October 17, 2008. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to ˜ a disability, please contact Carlos Pena at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/oc/advisory/ default.htm for procedures on public VerDate Aug<31>2005 21:01 Oct 08, 2008 Jkt 217001 59635 conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.regulations.gov. Dated: October 3, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–24051 Filed 10–8–08; 8:45 am] 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: BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–D–0520] Draft Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products; 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: Potency Tests for Cellular and Gene Therapy Products’’ dated October 2008. The draft guidance document provides manufacturers of cellular and gene therapy (CGT) products with recommendations for developing tests to measure potency. The recommendations are intended to clarify the potency information needed to support an Investigational New Drug Application (IND) or a Biologics License Application (BLA). 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 January 7, 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 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 I. Background FDA is announcing the availability of a draft document entitled ‘‘Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products’’ dated October 2008. The draft guidance document provides manufacturers of CGT products with recommendations for developing tests to measure potency. The recommendations are intended to clarify the potency information needed to support an IND or a BLA. Because potency measurements are designed specifically for a particular product, the guidance does not make recommendations regarding specific types of potency assays, nor does it propose criteria for product release. 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 The 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 21 CFR part 211 has been approved under 0910–0139, expiration date September 20, 2008; the collections of information in 21 CFR part 312 has been approved under 0910–0014, expiration date May 31, 2009; the collections of information in 21 CFR part 601 has been approved under 0910–0338, expiration date June 30, 2010. III. Comments The draft guidance is being distributed for comment purposes only and is not intended for implementation E:\FR\FM\09OCN1.SGM 09OCN1 59636 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Notices 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 https://www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the draft guidance at either https://www.fda.gov/cber/guidelines.htm or https://www.regulations.gov. Dated: October 1, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–24052 Filed 10–8–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Comment Request Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, e-mail paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301) 443– 1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Health Professions Student Loan (HPSL) Program and Nursing Student Loan (NSL) Program Administrative Requirements (Regulations and Policy) (OMB No. 0915–0047)—Extension The regulations for the Health Professions Student Loan (HPSL) Program and Nursing Student Loan (NSL) Program contain a number of reporting and recordkeeping requirements for schools and loan applicants. The requirements are essential for assuring that borrowers are aware of rights and responsibilities, that schools know the history and status of each loan account, that schools pursue aggressive collection efforts to reduce default rates, and that they maintain adequate records for audit and assessment purposes. Schools are free to use improved information technology to manage the information required by the regulations. The annualized estimates of burden are as follows: RECORDKEEPING REQUIREMENTS Number of recordkeepers Regulatory/section requirements HPSL Program: 57.206(b)(2), Documentation of Cost of Attendance ............................................. 57.208(a), Promissory Note ................................................................................... 57.210(b)(1)(i), Documentation of Entrance Interview ........................................... 57.210(b)(1)(ii), Documentation of Exit Interview ................................................... 57.215(a)&(d), Program Records ........................................................................... 57.215(b), Student Records ................................................................................... 57.215(c), Repayment Records ............................................................................. Hours per year Total burden hours 432 432 432 * 472 * 472 * 472 * 472 1.17 1.25 1.25 0.33 10 10 18.75 505 540 540 156 4,720 4,720 8,850 HPSL Subtotal ................................................................................................. NSL Program: 57.306(b)(2)(ii), Documentation of Cost of Attendance ......................................... 57.308(a), Promissory Note ................................................................................... 57.310(b)(1)(i), Documentation of Entrance Interview ........................................... 57.310(b)(1)(ii), Documentation of Exit Interview ................................................... 57.315(a)(1)&(a)(4), Program Records .................................................................. 57.315(a)(2), Student Records ............................................................................... 57.315(a)(3), Repayment Records ......................................................................... 472 .............................. 20,031 300 300 300 * 435 * 435 * 435 * 435 0.3 0.5 0.5 0.17 5 1 2.51 90 150 150 74 2,175 435 1,092 NSL Subtotal ................................................................................................... 435 .............................. 4,166 * Includes active and closing schools. HPSL data includes active and closing Loans for Disadvantaged Students (LDS) program schools. REPORTING REQUIREMENTS Number of respondents sroberts on PROD1PC70 with NOTICES Regulatory/section requirements HPSL Program: 57.206(a)(2), Student Financial Aid Transcript .......................................... 57.208(c), Loan Information Disclosure 57.210(b)(1)(i), Entrance Interview ....... 57.210(b)(1)(ii), Exit Interview .............. VerDate Aug<31>2005 21:01 Oct 08, 2008 Jkt 217001 PO 00000 Responses per respondent 4,600 432 432 * 472 Frm 00041 Total annual responses 1 68.73 68.73 12 Fmt 4703 Sfmt 4703 Hours per response 4,670 29,692 29,692 5,664 E:\FR\FM\09OCN1.SGM .25 .0833 0.167 0.5 09OCN1 Total hour burden 1,150 2,473 4,959 2,832

Agencies

[Federal Register Volume 73, Number 197 (Thursday, October 9, 2008)]
[Notices]
[Pages 59635-59636]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-24052]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0520]


Draft Guidance for Industry: Potency Tests for Cellular and Gene 
Therapy Products; 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: 
Potency Tests for Cellular and Gene Therapy Products'' dated October 
2008. The draft guidance document provides manufacturers of cellular 
and gene therapy (CGT) products with recommendations for developing 
tests to measure potency. The recommendations are intended to clarify 
the potency information needed to support an Investigational New Drug 
Application (IND) or a Biologics License Application (BLA).

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 January 7, 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 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 draft document entitled 
``Guidance for Industry: Potency Tests for Cellular and Gene Therapy 
Products'' dated October 2008. The draft guidance document provides 
manufacturers of CGT products with recommendations for developing tests 
to measure potency. The recommendations are intended to clarify the 
potency information needed to support an IND or a BLA. Because potency 
measurements are designed specifically for a particular product, the 
guidance does not make recommendations regarding specific types of 
potency assays, nor does it propose criteria for product release.
    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

    The 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 21 CFR part 211 has been approved under 
0910-0139, expiration date September 20, 2008; the collections of 
information in 21 CFR part 312 has been approved under 0910-0014, 
expiration date May 31, 2009; the collections of information in 21 CFR 
part 601 has been approved under 0910-0338, expiration date June 30, 
2010.

III. Comments

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation

[[Page 59636]]

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 https://www.regulations.gov.

IV. Electronic Access

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

    Dated: October 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-24052 Filed 10-8-08; 8:45 am]
BILLING CODE 4160-01-S

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